Careers

Porton Biopharma has approximately 400 staff in a wide range of roles from those working in our pharmaceutical manufacturing plants, through to our quality and scientific development groups.  All focused on developing & manufacturing life-saving products that make a real difference to patients’ lives.

We are always looking for people, ranging from those with a general interest in science & technology, to ones with higher qualifications and/or experience.

This currently includes various vacancies for pharmaceutical production staff and supervisors to support our continued growth.  So if you are a motivated person who is interested in working in a high-tech environment as part of a dynamic team, then there could be a role for you.

Laboratory

 

Training

 

Freeze Dryer

 

Quality Control

WE OFFER…

A friendly environment working alongside committed teams of people, who will be happy to share their knowledge and experience to allow you to develop your potential, with benefits that include:

  • a competitive salary
  • the necessary training
  • a pension scheme
  • 30 days annual leave
  • life-assurance cover
  • free on-site parking

With ongoing investment into the company and plans to increase our workforce, we are committed to being a leading life-science company that really makes a difference to patients’ lives.

To see the sort of  people that we ‘re looking for, the  Staff Profiles page has short interviews with current staff giving an overview of just some of our roles.

CURRENT VACANCIES…

PBL only accept CV’s from Recruitment Agencies with whom we have agreed Terms & Conditions.

A list of our current vacancies shown below.

To apply for a specific vacancy applicants should  send a covering letter quoting the Job Reference Number, a copy of their CV, together with a supporting statement referring to both the Job Description and Person Specification.

However, we also welcome applications from people with transferable skills that are looking for that next challenge and to develop their career.  To be considered for up-and-coming roles please send a covering letter indicating why you want to join PBL and in which area your career aspirations lie (Engineering  / Production  / Quality etc.),  along with a CV detailing your skills and experience which we can keep on file for when a suitable position becomes available.

All applicants should check our Recruitment Privacy Policy and all applications should be sent to recruitment@portonbiopharma.com.

PBL is an equal opportunities employer, celebrating and encouraging diversity of applications.

Porton Biopharma Ltd is committed to the fair and transparent processing of applicant data. To enable the Company to assess suitability for advertised roles, we will collect the following data: name and contact details, previous work experience and history, qualifications, education, right to work in the UK eligibility, present salary and equal opportunities. The Company reserves the right to collect this data under article 6(1)(B) of the GDPR.

Applicants applying for roles will have their data collected and held securely, and confidentially within Company IT systems which are compliant with GDPR. Data will be shared with the HR department, recruiting managers and recruiting panel.

The Company will hold applicant data on file for 12-months post the vacancy being successfully filled. Candidates are welcome to request that their personal data is removed prior to this date, and should contact recruitment@portonbiopharma.com if they wish to exercise this right. The Company complies with all data subject rights as outlined on the ICO Website. For more information, please refer to our privacy notice: https://www.portonbiopharma.com/privacy-policy/.

PBL674 Executive Assistant

Salary: Circa £27,000 per annum, dependant on experience

Closing Date: 28th September 2021

Reference Number: PBL674

The successful candidate will be joining the HR & Administration Department who are responsible for providing high quality support to the Chief Executive Officer (CEO). As an Executive Assistant for Porton Biopharma, the post holder will provide high quality secretarial and administrative support to the PBL Board, coordinating and attending meetings, taking accurate minutes, and acting as first point of contact for the Board/Executive team. To provide high quality administrative support to the Chairman of the Board.

Key responsibilities

  • To provide PA/administrative services including diary management, booking meetings, planning events, organising travel, and preparing travel itineraries, correspondence and prioritising calendar appointments and emails for the CEO.
  • To provide administrative support to the Chairman of the PBL Board organising travel, diary management, inbox and calendar management, preparing briefing materials (or other documents) for the Chairman.
  • To follow up on action points from meetings on behalf of the Chairman and CEO.
  • To provide high quality administrative support to the PBL Board, coordinating and attending meetings in Porton and London (other locations if necessary), taking accurate minutes and acting as the first point of contact for the Board.
  • To coordinate members of the PBL Board to meet governance and decision-making processes in a timely manner.
  • To coordinate Executive Team meetings, attending meetings and taking minutes, follow up actions to ensure key messages and decisions are communicated to the Executive Group.
  • Coordinate multiple administrative projects as assigned by the Chairman and CEO.
  • Proactively and effectively manage a complex diary, paying close attention to detail and accuracy, making decisions regarding appropriate use of time and resources, as appropriate and necessary.
  • Act as a ‘gatekeeper’ to make the best use of the CEO’s time, taking the initiative to seek advice from colleagues and paying close attention to both immediate priorities and longer-term planning.
  • Plan high-level meetings, visits, and events in line with the CEO’s guidelines, ensuring all details are confirmed and correct.
  • Initiate and maintain regular meetings with key internal and external stakeholders.
  • To coordinate the circulation of monthly reports, team briefings and reports on behalf of the CEO.
  • Flag meetings and events in a timely manner, providing appropriate accurate information by obtaining briefings and updates from colleagues as appropriate.
  • Oversee the organisation of travel and accommodation in line with policies and procedures.
  • To comply with all PBL policies, procedures, legal and regulatory requirements including Health & Safety, maintaining confidentiality including General Data Protection Regulations.
  • To maintain a comprehensive overview of all aspects of the CEO (and Chairman) administrative work, providing senior staff with updates on progress and acting as the main point of contact for all routine queries both internally and externally, displaying tact, diplomacy and discretion.
  • To be the main point of contact for the CEO, staff and stakeholders and therefore needs to have a detailed awareness of operational issues.
  • To establish strong working relationships with relevant counterparts and external stakeholders, ensuring a prompt and professional approach to maintain positive relations and build on existing networks.
  • To hold a company credit card and track all expenditure as required.
  • Any other duties commensurate with the accountabilities of the post.

 Person Specification

  • Have current right to work in the UK;
  • A Degree or minimum of a Level 3 in Business & Administration
  • PA/Advisor experience
  • Strong communication, time management and administration at high level

To download the job description please click here

PBL546 QMS Document Controller & GxP Archivist (12 mths Fixed Term)

Salary: Circa £20,200 per annum, dependant on experience

Reference Number: PBL546

The successful candidate will be joining the Quality Assurance Documentation Team who are responsible for the administration of documentation within the EQMS System and provide a variety of Document Control functions / services which include document creation, formatting, scanning and controlled distribution of PBL documents

The post holder will: Work with minimal supervision, to strict deadlines, methodically and to a high degree of accuracy to maintain records and filing systems to ensure adequate control of documents. Performance of additional general office and administrative duties to support the activities of QA Groups e.g. filing, archiving, ordering supplies etc.

We are looking for: An applicant who has excellent communication skills in addition to good customer focus with a drive and determination to succeed in maintaining the current exceptional service levels. Using strong organisational and data entry skills the successful applicant will work within a small team to maintain a critical aspect of the site’s Quality Management System (Document Control and Archive Service).

Key responsibilities

  • To manage and maintain the necessary tracking system(s) / database(s)
  • To liaise with internal customers to ensure efficient and effective processing of Quality Documentation and resolution of customer queries
  • Make decisions on processing Quality Documentation based on content and as guided by SOPs
  • Use computerised systems including inputting multiple critical data entries which require a high degree of accuracy
  • Provision of first line support, via email, telephone or face-to-face, with service users to ensure compliance with defined processes and effective processing
  • Provision of training both to individuals and groups, including the generation and assessment of training materials
  • To provide general office administrative support to the team, e.g. Filing, photocopying, stock control, arranging meetings, room bookings, car hire etc.

Person Specification

  • Have current right to work in the UK;
  • 5 GCSEs or equivalent, including English, Maths and a Scientific subject.
  • Previous experience of working in an administrative environment using computerised data systems, document control or archive experience.
  • Working knowledge of Microsoft Office, including Word and Excel.

To download the job description please click here

PBL673 Process Validation Specialist

Salary: Circa £29,355.00 - £43,000.00 per annum, dependant on experience

Reference Number: PBL673

The successful candidate will be joining the Process Validation team within the Validation Department, who are responsible for the execution of Performance Qualification and Process Performance Qualification activities in support of PBL manufacturing activities and in accordance with Regulatory requirements.

As a Process Validation Specialist for Porton Biopharma, the post holder will be expected to attend project group meetings, liaise with PBL support teams, regulatory bodies and peers to establish data for inclusion in protocols and reports.

Key responsibilities

  • To coordinate the execution of the Validation Master Plan with respect to Process Validation activities.
  • Assess Change control documentation to determine change impact with respect to the validation requirements and report appropriately.
  • To support operational areas in the implementation of change.
  • Support Process Validation activities.
  • Define Process Validation Strategies in conjunction with the Process Validation Lead.
  • Author and review Process Validation plans, protocols and reports ensuring compliance to PBL policies and procedures.
  • Schedule and support Process Validation executions.
  • High level of technical and scientific writing required.
  • Understand and Applies statistical tools for development of protocols and data analysis for Process Validation (as per current FDA/MHRA Process validation lifecycle guidelines). Participate in Continued Process Verification Activities (CPV) including the generation of CPV plans and CPV reporting.
  • Present Process Validation documents at regulatory audits.
  • Performs process investigations with relevant departments as required.
  • Performs product and process impact assessments.
  • Participates in or Lead process and quality risk assessments
  • Presents findings at group and at interdepartmental meetings.
  • Communicate information on current process data which may impact Process Validation.
  • Maintain and review the Product Control Strategy for all products. Understand the functional relationships that link CMA/CPP to CQA.
  • To ensure the timely completion of Deviations and the closure of CAPAs.

 Person Specification

  • Have current right to work in the UK;
  • Degree in Science or Engineering or equivalent and recognised academic achievement.
  • Understanding of the Validation Life Cycle.
  • Project Management experience.
  • Management of internal customer expectations.
  • Statistical package use.
  • Good computer skills: Word, Excel.
  • Validation experience ideally within a Biopharmaceutical environment.
  • Biotechnology experience.
  • Statistical evaluation of data.
  • Coordination of cross functional teams.

To download the job description please click here

PBL671 Senior Asset Officer

Salary: £40,000.00 per annum

Closing Date: 10th September 2021

Reference Number: PBL670

The successful candidate will be joining the Engineering group, who are responsible for provision of all engineering support within the highly regulated GMP Facilities at PBL Porton Down. This structure includes engineering functions provided by professional engineers specialising in clean rooms, GMP critical utilities, production equipment, pharmaceutical facilities, and capital works delivery. As a Senior asset officer for Porton Biopharma, the post holder will be responsible for the asset management of all PBL assets using (MAXIMO CMMS). This will include initial onboarding of assets through to creation of Preventative maintenance schedules to ensure compliance of PBL eqpt. PM’s will also be set to ensure instruments are routinely calibrated to their required intervals.

The Senior asset officer will also be the subject matter expert for instrumentation and calibration for Engineering and the Projects Dept. Additionally the role is responsible for carrying out reliability studies of instruments, techniques and trending of failures.

Assisting with the management of the PBL engineering stores will play an essential part of this role, to verify the best possible options for instrumentation spares in order to maintain compliance.

This role requires specialist and detailed knowledge of the critical Legal & Regulatory procedures and industry best practice for instrumentation.

The Senior asset officer will report directly to the Asset Manager within the asset management team providing both technical and asset management support.

The role will be required to continuously liaise with Engineering, Production, Calibration, QA, Validation and External specialist contractors to ensure production facilities meet the scheduled and regulatory requirements to deliver Erwinase and Anthrax Vaccine and minimize disruption

Key responsibilities

  • Asset on-boarding using the site asset management system.
  • Working closely with new project implementation as SME for the Asset management team and Calibration
  • To onboard of assets to Maximo with the correct job plans and preventative maintenance schedules.
  • Ensuring all PBL equipment and utilities are accurately linked for traceability through MAXIMO CMMS
  • Regular review of all asset related non-conformances to identify any failure trends and provide recommendations to eliminate or improve practices, to minimise failures and ultimately reduce numbers of non-conformances generated within PBL the engineering department.
  • Provide the required specialist technical input to ensure preventative maintenance schedules are designed to ensure PBL assets meet the required level of compliance and reliability.
  • Liaising with instrumentation suppliers and specialist engineering contractors to ensure compliance is adhered to at all times with new supplied instrumentation and contracted resource.
  • Utilise SME status to assist with management of engineering stores using detailed knowledge of current calibration practices and instrumentation to ensure compliance at all times.

 

Person Specification

  • Have current right to work in the UK;
  • A good standard of written and spoken English   Language
  • Educated to degree level in a life/applied science subject or equivalent level qualification or significant experience of working at a similar level in delivery of calibration services.
  • Experience in Preparing Detailed GMP Engineering Technical Documentation.
  • UKAS Accreditation
  • Experience of current available Pharmaceutical Instrument technology and its subsequent sizing/selection to support Pharmaceutical Operation.
  • Experience of working within a GMP Quality System, in particular, change control, Non-Conformance management, CAPA, discrepancy/deviation, and documentation management.
  • Experience of dealing with internal customers, negotiating and agreeing work programmes, reporting progress, dealing with issues to ensure delivery and customer satisfaction
  • Specialist knowledge of Calibration of equipment relating to GMP pharmaceutical production Facilities
  • Diplomatic and tactful approach to colleagues and good communication skills.

To download the job description please click here

PBL670 Audit & Supplier Assurance Manager

Salary: Circa £50,000.00 per annum, dependant on experience

Reference Number: PBL670

We are seeking an experienced and dynamic Audit and Supplier Assurance Manager to join our QA team and to be responsible for the leadership and management of the Audit and Supplier Management team.

The position is based in the Quality Department where several key activities are undertaken to deliver compliance and continuous improvement across PBL.

The role will report to the QMS Manager and will be responsible for the leadership and management of the internal and supplier management teams and associated systems.

 Key responsibilities:

The Audit and Supplier Assurance Manager, will be responsible to:

  • Provide leadership and Management the audit team.
  • Manage the audit and supplier approval management system, including; scheduling, site audits, questionnaires, BSE/TSE assessments.
  • Maintain procedures and processes for auditing and supplier assurance activities.
  • Undertake site audits of critical suppliers and advice on their suitability for PBL.
  • Undertake internal audits of PBL activities supporting the manufacture and testing of PBL products.
  • Ensure data integrity requirements are included into PBL site internal audits.
  • Liaise with internal customers, production staff, and quality staff to promote compliance with GMP and with internal customer requirements.
  • Manage and maintain Quality Technical Agreements with critical suppliers and sub-contractors.
  • Negotiate corrective and preventative actions necessary to achieve compliance.
  • Participate in hosting third part and regulatory audits/visits.
  • Provide technical and compliance guidance to project teams.
  • Keep upto date with regulatory requirements and technical advances and interpret their relevance/impact upon the team.
  • In line with responsibilities. to perform other tasks assigned or objectives set by Line Management.
  • Assist with the QA overview of manufacturing and testing areas.
  • Provide KPI reports measuring the performance of the team.
  • Undertake relevant training
  • Undertake work in accordance with PBL Health and Safety policies and procedures and to work within the Quality System that are applicable to the site.
  • Comply with PBL policies and procedures.

Person Specification

 Essential

  • Educated to degree level or HND in a relevant subject or equivalent level of experience of working at a similar level in specialist area
  • Experience in operating quality systems in a GMP environment
  • Proven experience in auditing to GMP and with Lead Auditor Qualifications.
  • Competent preparing and providing accurate and timely documentation.
  • Working knowledge of GMP, GCP, GLP, GDP and/or ISO
  • Comfortable working with multiple tasks and prioritising workload
  • Ability to communicate with a wide range of people
  • Strong documentation skills

Desirable

  • Membership of IQA, RQA or equivalent
  • Practical experience in GMP manufacture, QC testing, validation or engineering.
  • Experience in training/troubleshooting within teams
  • Experience of using an eQMS or LIMS
  • Ability to deliver challenging messages in a constructive manner

 

To download the job description please click here

PBL669 Production Technician (Immuno)

Salary: £20200.00 gross per annum

Closing Date: 3rd September 2021

Reference Number: PBL669

The successful candidate will be joining the Immuno Department who are responsible for the manufacture of Anthrax Vaccine bulk concentrate. As a Production Technician for Porton Biopharma, the post holder should have an interest in working within a manufacturing environment and with the Quality systems associated with cGMP manufacture. They should be able to communicate clearly, possessing good writing and data entry skills. Lastly applicants should be able to work effectively as part of a team, be proactive and able to work on their own initiative when required. The successful candidate will report to the Production Supervisor and will support the Production Supervisor to meet team targets by ensuring manufacturing operations are performed in a timely and compliant manner to cGMP requirements.

Key responsibilities

  • Perform a range of routine Production and some non-routine technical procedures and understand the rationale behind the procedures and practices
  • Undertake all work in accordance with PBL’s Code of Safety Practice, Quality System and all other regulatory requirements.
  • Follow defined procedures, policies, rules, regulations and guidelines for all activities to ensure product meets the required standard.
  • Generate and review documentation with regard to Risk Assessments and cGMP to ensure compliance of the unit with all necessary regulations.
  • Work diligently at all times. Complete documentation and records accurately and to a high standard.
  • Ensure the unit is maintained in a compliant state. Work to cGMP following Standard Operating Procedures (SOPs) and Codes of Practice. Keep updated on new rules and regulations.
  • Maintain production areas to the required standard using defined cleaning procedures.
  • Perform and record environmental monitoring and water sampling in cGMP areas in accordance with documented procedures. Monitor and record air pressures and hot and cold facility temperatures.
  • Perform a range of routine Production and some non-routine technical procedures and understand the rationale behind the procedures and practices.
  • Undertake all work in accordance with PBL’s Code of Safety Practice, Quality System and all other regulatory requirements.
  • Follow defined procedures, policies, rules, regulations and guidelines for all activities to ensure product meets the required standard.
  • Generate and review documentation with regard to Risk Assessments and cGMP to ensure compliance of the unit with all necessary regulations.
  • Work diligently at all times. Complete documentation and records accurately and to a high standard.
  • Ensure the unit is maintained in a compliant state. Work to cGMP following Standard Operating Procedures (SOPs) and Codes of Practice. Keep updated on new rules and regulations.
  • Maintain production areas to the required standard using defined cleaning procedures.
  • Perform and record environmental monitoring and water sampling in cGMP areas in accordance with documented procedures. Monitor and record air pressures and hot and cold facility temperatures.
  • Analyse information and make decisions based on assessment.
  • Assist validation department with validation protocols on equipment.
  • Maintain and use a variety of laboratory equipment.
  • Work with a range of hazardous and non-hazardous chemicals.
  • Be competent in and perform aseptic techniques.
  • Be qualified to work in a clean room environment and in containment level 3 suites.
  • Work accurately and with good hand eye co-ordination, sometimes for prolonged periods of time.
  • Operate autoclaves and sterilising ovens and have an appropriate level of understanding to review cycle data as a senior operator.

 

Person Specification

  • Have current right to work in the UK;
  • GCSE (grades A – C) in Maths, English and Science or relevant experience
  • Two A levels or equivalent or prior experience in a relevant industry
  • NVQ3 or equivalent and prior experience or HND
  • Worked within a manufacturing environment and with the Quality systems associated with cGMP manufacture.
  • Successful applicants must either hold, or be capable of obtaining, a UK government security clearance at SC level.  To obtain clearance at this level you must have been resident in the UK for the last five years, and not lived abroad for more than six months out of the last twelve.

To download the job description please click here

PBL667 Validation Technologist

Salary: Circa £36,460.00 per annum, dependant on experience

Reference Number: PBL667

The successful candidate will be joining the Validation Department who support the qualification of equipment, facilities and utilities with an experienced knowledge base of Computer System Validation, Cleaning Validation, Process Validation and the delivery of capital equipment into beneficial use.

The purpose of this role is to execute validation activities relating to Equipment (Process and Sterilisation), Facilities and Utilities. This will involve coordination with Engineering, Production, QC and QA departments to ensure a timely delivery of the qualification activities and documentation.

Key responsibilities

The post holder will be required to write, review and where appropriate approve validation protocols prior to execution, followed by report generation. The core activities will include qualification of:

Autoclaves (BSEN 285)

  • Depyrogenation ovens
  • Extraction Tanks
  • Centrifuges
  • Vessels
  • Facilities and Utilities

Person Specification

  • Have current right to work in the UK.
  • 5 GCSEs or equivalent including maths and English.
  • Hands-on experience of facilities and utilities qualification.
  • Biopharmaceutical experience.
  • BSEN-285 – Sterilisation, steam sterilisers, large sterilisers.
  • Understanding of the validation life cycle.
  • Equipment validation.
  • Risk based approach to validation.
  • Use of Datalogger (V2K) and Val Probe equipment and software.
  • Demonstrated skills and capability in planning, preparing, executing and reporting of validation activities.

To download the job description please click here

PBL664 Head of Process Technology & Support

Salary: Circa £70-£75K per annum, dependant on experience

Reference Number: PBL664

The successful candidate will be a dynamic, experienced individual with a strong track record of leadership experience across a variety of settings and topics in the pharmaceutical or biopharmaceutical industry. Working alongside the CEO/Executive team, the job holder will not only be expert in the development of new biopharmaceuticals but will also be commercially aware of the bioprocess industry; advising on the best path of growth for the business and future commercialisation options.

The individual will also be required to play a key role in supporting the Process Technology team in supporting associated manufacturing processes and analytics, as well as providing expert support to existing licensed products. The individual will, working with their senior team, drive projects in the areas of both manufacturing capacity and product extension work, ensuring that the appropriate resource is identified and in place and that projects are delivered on time and to budget.

Key Responsibilities

  • Working with senior managers in the current Process Technology team, and where appropriate cross-functionally across the business, lead, manage and direct various change management programmes, ensuring that resources are available and in place, with delivery according to agreed timescales. Establish strategies that meet project and regulatory requirements, in collaboration with the Executive team and expert consultants.
  • Develop and maintain suitable project schedules, budgets and risk mitigation plans with project teams and external service providers if necessary.
  • Liaise with service providers on a regular basis to monitor progress against milestones; review and manage technical data and documentation to ensure timely action.
  • Contribute to the development of company’s strategy, challenging assumptions and decision-making as appropriate and providing an appropriate guidance on all activities, plans, targets and business drivers.
  • Design and manage an integrated financial budget for the department to ensure that the business is in delivery of its financial objectives and maximises department’s contribution to PBL.
  • To promote and uphold the highest standards of professionalism to create, maintain and enhance the reputation of PBL amongst its customers and stakeholders, both nationally and internationally.
  • To grow and develop the business through the identification and exploitation of opportunities and by establishing strategic collaborations and interactions with third parties, including public and private sector bodies.
  • To support and contribute to the delivery of continuous improvement in all areas of the business to enhance the quality, delivery, rate of growth and competitiveness. Coordinate support and cooperation between the education sector (Universities, etc.) and PBL. To take responsibility for all HR issues within the department; maximising team performance by sharing goals and objectives, leading the team to operational success. Mentoring and coaching staff to enable high performance, skills development and to nurture talent.
  • To take Executive responsibility for PBL Health & Safety and management of the Health & Safety Manager. Oversee the implementation, management and delivery of all H&S policies, arrangements and procedures across PBL.
  • To ensure that all duties are performed in line with PBL Health & Safety Policy and ensure safe working practices and that staff are aware of individual responsibilities under the H&S Policy; the Fire Safety Policy and other H&S regulations.
  • To contribute to publications in national and international journals; to review scientific communication (abstracts, articles, presentations, etc.) for internal and external purposes
  • Work with senior teams to grow the business, formulating strategies and plans. To comply with ethical, scientific, GMP, etc. guidelines and statutory principles throughout all departmental activities.
  • To ensure that strategic and operational plans, goals and objectives are documented, communicated, reviewed and evaluated on a continuous basis.
  • Advise CEO on critical issues deserving immediate attention and escalation, proposing actionable solutions.
  • Establish a high level of credibility and manage strong working relationships with external parties including customers, advisors and auditors.

Person Specification

  • Have current right to work in the UK;
  • PhD/Masters or equivalent in Biological Services
  • An MBA or equivalent senior management experience in the field of biopharmaceutical product development.
  • Advanced experience of managing a successful pharmaceutical business.
  • Demonstrated expertise in project management, applied preferably within a multi‑disciplinary R&D environment, with a strong track record of successful delivery.
  • Corporate awareness; financial and commercial management.
  • Proven leadership and managerial experience in a matrix management environment.
  • Awareness of the regulatory and pharmaceutical environment.
  • Evidence of continuing professional development.
  • Ability to interrogate and interpret data, problem-solve, make sound decisions and recommendations.
  • Exceptional communication skills in a complex multi-stakeholder context.
  • Collaborative leadership and management skills.
  • Ability to handle high levels of pressure and critical decision making. Substantial practical and academic experience.
  • Experience in the setting of specifications for drug products.
  • Ability to build and influence internal and external partnerships. Ability to work cohesively/collaboratively across the organisation.
  • Highest level of integrity and confidentiality; ability to interpret and provide advice on H&S and risk management issues.
  • Ability to learn and apply new industry knowledge, sales processes and techniques quickly and effectively to demonstrate faster results.

To download the job description please click here

PBL665 Health & Safety Manager

Salary: Circa £50,000.00 per annum, dependant on experience

Reference Number: PBL665

The job holder will be required to work closely with managers across PBL to assess their needs and ensure the delivery of H&S plans. The job holder will also be required to work closely with a number of committees and groups, particularly the PBL Safety Group and the PHE Porton Site Safety Committee. In addition, the post holder will liaise with Executive Directors, Operational Managers, Project Managers and other parts of PBL, e.g. Production and Quality.

The post holder will be required to work closely with a number of external stakeholders such as HSE and other regulators and represent PBL on matters relating to H&S for example the UK Regulatory Agencies.

Key Responsibilities

  • Develop and execute H&S plans in the workplace according to legal guidelines.
  • Prepare and enforce policies to establish a culture of H&S. Evaluate practices, procedures and facilities to assess risk and adherence to the law.
  • Work proactively with managers and other key staff to establish and maintain a programme of continuous improvement in the management of H&S, well-being, etc. Within their areas of responsibility.
  • Ensure that rigorous risk assessment and incident management systems are in place and followed across the organisation. Accountable for setting and overseeing the incident investigation process.
  • Conduct training and presentations for H&S matters and accident prevention.
  • Oversee the adherence to the PBL Safety Improvement plan. Recommend solutions to issues, improvement opportunities or new prevention measures.
  • Maintain close liaison with management, scientific, technical, engineering, maintenance and administrative staff to ensure high standards of H&S.
  • Actively maintain high levels of awareness of H&S practices and legislation; monitor compliance to policies and H&S laws.
  • Maintain and develop a high level of understanding of the nature and significance of the work carried out by the scientific, technical, engineering, maintenance and administrative staff of PBL.
  • Manage a system of auditing and seeking assurance of H&S in accordance with PBL policies and procedures.
  • Take a lead role in the development of H&S standards and systems across PBL.
  • Participate and lead as necessary in emergency and unplanned events and participate in safety groups and in investigations of accidents and incidents as required.
  • Maintain in an appropriate form such records and systems as are necessary to fulfil H&S policy, including those containing confidential information.
  • Maintain H&S competences to national standards.
  • To comply with all PBL policies and procedures.
  • To perform any other duties as per instructions of line manager/senior management.

Person Specification

  • BSc/BA in safety management or relevant field
  • NEBOSH Certificate/Diploma
  • Proven experience as a safety manager
  • 3-5 years experience in a health and safety role
  • Experience of managing health & safety activities
  • Knowledge of statutory requirements
  • Specialist skills in GMP and biological safety
  • Experience of managing related hazards, such as fire, environment etc
  • Experience of leading committees and working groups
  • Deep understanding of legal H&S guidelines
  • Experience of managing a training and audit programme
  • Completing H&S Audits nd implementing action plans
  • Exceptional communication skills, attention to detail and time management

To download the job description please click here

PBL656 Unit Manager (Downstream Processing)

Salary: Circa £29,355.00 - £43,000.00 per annum, dependant on experience

Closing Date: 6th August 2021

Reference Number: PBL656

The successful candidate will be joining the Production Department, who are responsible for the purification of Drug Substance and the manufacture of buffer solutions. As a Unit Manager for Porton Biopharma, the post holder will manage all of the aspects of the production Units involved in this role.

Key responsibilities

  • Implement and utilise a range of production methods and procedures in support of all activities associated with manufacturing.
  • To ensure the facilities are maintained and fit for purpose.
  • Ensure all support activities including Engineering and Validation, required to ensure GMP compliance are scheduled and executed.
  • Supervision and training of staff
  • Responsible for the generation of Non Conformances, CAPAs, Risk Assessments and Change Controls
  • Ensure the unit is ready at all times for audit by any regulatory organisation
  • Responsible for the provision of all consumables and, supplies required for day to day activity.
  • Identify, evaluate and adapt new technologies where appropriate and ensure that the production area operates to a high standard and complies with GMP and other regulatory standards.
  • Provide reports on all aspects of manufacturing as requested.

 Person Specification

  • Have current right to work in the UK;
  • Someone with a degree in a biological sciences or relevant discipline, or significant relevant experience
  • Experience working in a clean room environment including a management/supervisory role in GMP manufacturing environment
  • Writing and reviewing batch documentation and SOPs
  • Downstream processing experience
  • Batch and facility planning to support schedules including monitoring, adjusting and ensuring compliance with schedules
  • Experience of managing teams of technical staff
  • Comprehensive understanding of critical utilities, calibration, Validation, and maintenance activity associated with a GMP environment

 

To download the job description please click here

PBL655 CSV Specialist

Salary: Circa £35,000.00-£45,000.00 per annum, dependant on experience

Reference Number: PBL655

Porton Biopharma Limited (PBL) is a limited liability company, established in 2015, to commercialise pharmaceutical development and manufacturing capabilities.  Our mission is to protect patients’ health through the quality-assured development and production of biopharmaceuticals.  We develop new vaccines, therapeutic proteins and enzyme products, and manufacture our own licensed biopharmaceutical products, Erwinase® and the UK’s Anthrax Vaccine.

We offer specialist expertise in the development of both manufacturing and analytical processes for use with biological pharmaceutical products. Particularly in taking concepts from the research laboratory and progressing them through the various stages of scale-up and process development to manufactured product for licensed supply or clinical trial.

Our employees join us safe in the knowledge that their skills and experience are contributing to a valuable purpose. This is an excellent environment for the right person to build their biopharmaceutical career.

The Computer Systems Validation Specialist will be in receipt of a competitive benefits package, including:

  • 30 days of holiday, plus 8 bank holidays;
  • On the job training, and genuine opportunities for growth and advancement;
  • Generous pension scheme;
  • Access to online discounts;
  • A work environment based in the beautiful Salisbury countryside, with free on-site parking; easy access to London and the south coast
  • Onsite canteen
  • Onsite nursery
  • Life Assurance

The successful candidate will be joining the Computer Systems Validation team, who are responsible for the CSV activities in support of PBL manufacturing activities and in accordance with regulatory requirements.

As a Computer Systems Validation Specialist for Porton Biopharma, the post holder will be expected to balance multiple project and QMS based CSV activities including  attending project group meetings, liaise with PBL support teams, regulatory bodies and peers to establish the creation, review and execution of CSV / QMS documents in partnership with all relevant stakeholders.

Key responsibilities

  • Take the lead in computer system validation and compliance, manage and deliver specific validation projects according to the business priorities, including work scheduling and supervision of junior members of staff.
  • Comfortable working alone or within the management system and as part of a team.
  • Continuous improvement of validation systems and procedures to ensure efficiency and best practice within the industry and to stay abreast of changing regulatory expectations.
  • Write, review and approve validation documentation including protocols and reports and manage the timely closure of any discrepancies or non-conformities.
  • Providing a reliable service to our internal customers to ensure that timescales are met, and work is carried out to meet expectations.
  • Maintaining the ongoing compliant status of computer systems associated with equipment, facilities and utilities by involvement of the scheduling of activities.
  • Communicating validation activities with our internal and external customers and working with them to resolve problems and conflicts.
  • In line with overall responsibilities, perform additional tasks assigned by the line manager.
  • Undertake all work in accordance with Code of Safety Practice and site Quality Policies.

Person Specification

  • Have current right to work in the UK.
  • Degree in Science / Engineering or equivalent and recognised academic achievement.
  • Good understanding of validation principles and practices and a risk-based approach.
  • Experience of generation, execution and review of validation protocols, reports and technical documents.
  • Experience of quality systems including change control, deviation and CAPA
  • Experience of dealing with internal customers, identifying and delivering work programs, reporting progress and dealing with issues.
  • An understanding of EU and FDA regulatory requirements relating to validation including (but not limited to) UK/EU GMP Annex 11 and 21 CFR Part 11.
  • An understanding of GAMP processes.
  • Technical understanding of computerised systems such as PLCs, SCADA, networked enterprise systems, laboratory systems, databases, layered software as used in a GxP environment.
  • Good computer skills

To download the job description please click here

PBL652 QC Microbiologist

Salary: Circa £22,000.00 per annum, dependant on experience

Reference Number: PBL652

See Job Description for full details;

Key responsibilities

  • Perform Environmental Monitoring of clean rooms and Production areas as required
  • Undertake and perform microbiological QC analyses in support of Porton Biopharma’s licensed production, service, validation and developmental programs.
  • Carry out all work in compliance with cGMP
  • Test microbiological samples from all stages of the production processes of licensed and developmental products and to assess the results against pre-set standards and specifications
  • Undertake identification of micro-organisms isolated from microbiological tests and samples

Person Specification

  • Have current right to work in the UK;
  • Experience of environmental monitoring of clean rooms
  • Knowledge and experience of microbiology gained in a laboratory or similar environment.
  • An understanding of GMP and quality systems
  • Able to work methodically and to strict deadlines
  • To perform routine testing within the microbiology laboratory, on a day to day basis, of the Bacteriology Technical Services Unit.
  • Good understanding of QC microbiological assays and QC laboratory systems
  • Confident to train junior staff in processes and procedures

To download the job description please click here

PBL641 Senior Production Technician (Immuno)

Salary: Circa £20,500.00 per annum, dependant on experience

Reference Number: PBL641

The successful candidate will be joining the Immuno Unit, who are responsible for the manufacture of the UK’s licenced anthrax vaccine. As a Senior Production Technician for Porton Biopharma, the post holder will work in aseptic cleanrooms, using high-grade isolators for bulk processing activities, as well as maintaining and monitoring the facility and critical GMP records. The post holder should have an interest in working within a manufacturing environment and with the Quality systems associated with cGMP manufacture. They should be able to communicate clearly, possessing good writing and data entry skills. Lastly applicants should be able to work effectively as part of a team, be proactive and able to work on their own initiative when required. The successful candidate will report to the Production Supervisor and will support the Production Supervisor to meet team targets by ensuring manufacturing operations are performed in a timely and compliant manner to cGMP requirements.

Key responsibilities

  • Perform a range of routine Production and some non-routine technical procedures and understand the rationale behind the procedures and practices.
  • Undertake all work in accordance with PBL’s Code of Safety Practice, Quality System and all other regulatory requirements.
  • Follow defined procedures, policies, rules, regulations and guidelines for all activities to ensure product meets the required standard.
  • Generate and review documentation with regard to Risk Assessments and cGMP to ensure compliance of the unit with all necessary regulations.
  • Work diligently at all times. Complete documentation and records accurately and to a high standard.
  • Ensure the unit is maintained in a compliant state. Work to cGMP following Standard Operating Procedures (SOPs) and Codes of Practice. Keep updated on new rules and regulations.
  • Maintain production areas to the required standard using defined cleaning procedures.
  • Perform and record environmental monitoring and water sampling in cGMP areas in accordance with documented procedures. Monitor and record air pressures and hot and cold facility temperatures.
  • Analyse information and make decisions based on assessment.
  • Assist validation department with validation protocols on equipment.
  • Maintain and use a variety of laboratory equipment.
  • Work with a range of hazardous and non-hazardous chemicals.
  • Be competent in and perform aseptic techniques.
  • Be qualified to work in a clean room environment and in containment level 3 suites.
  • Work accurately and with good hand eye co-ordination, sometimes for prolonged periods of time.
  • Operate autoclaves and sterilising ovens and have an appropriate level of understanding to review cycle data as a senior operator.

 Person Specification

  • Have current right to work in the UK;
  • GCSE (grades A – C) in Maths, English and Science or relevant experience
  • Worked within a manufacturing environment and with the Quality systems associated with cGMP manufacture.
  • Successful applicants must either hold, or be capable of obtaining, a UK government security clearance at SC level.  To obtain clearance at this level you must have been resident in the UK for the last five years, and not lived abroad for more than six months out of the last twelve.

To download the job description please click here

PBL638 Senior Production Technician (B20 Seed + shift)

Salary: Cira £20,500.00 per annum plus 30% shift allowance, dependant on experience

Reference Number: PBL638

See Job Description for full details;

Key responsibilities

  • To carry out duties involved in the manufacture of biopharmaceuticals to GMP and ISO 9001 requirements as directed.
  • Ensure that the facility is maintained in a compliant state and that the product/materials are manufactured to appropriate regulatory requirements.
  • To undertake all necessary training to enable the post holder to carry out their duties to a required standard.
  • To undertake work in accordance with PBL Health and Safety Policies and procedures and to work within any Quality systems that are appropriate to the site.
  • To comply with all PBL policies and procedures.
  • In line with any other responsibilities, to perform any other tasks assigned by the Line Manager.

 Person Specification

  • Have current right to work in the UK;
  • GCSEs in English, Maths and Science or equivalent qualifications.
  • A NVQ level 2 in a relevant subject or equivalent, or relevant experience.
  • Successful applicants must either hold or be capable of obtaining a UK government security clearance at SC level. To obtain clearance at this level you must have been resident in the UK for the last five years and not lived abroad for more than six months in the past twelve.

 

To download the job description please click here

PBL636 Senior Microbiologist

Salary: Circa £27,000 per annum, dependant on experience

Reference Number: PBL636

Key responsibilities

  • Operate in compliance in GMP and quality systems
  • Knowledge and experience of Quality Management Systems including non-conformances, change management and quality risk management
  • Undertake and perform environmental monitoring in the facilities that manufacture Erwinase and the Anthrax Vaccine.
  • Able to work with minimal supervision and to strict deadlines
  • Supervise and organise the workload, on a day to day basis, of yourself and junior members of staff.
  • Strong understanding of environmental monitoring techniques and gowning processes. Understanding of bioburden, endotoxin, water testing, disinfectant efficacy and environmental monitoring as well as microbial identification is beneficial.
  • Confident to train junior staff in processes and procedures
  • Perform data verification of test data and results

Person Specification

·Have current right to work in the UK;

·We are looking for a candidate who has a high level of knowledge, understanding and practical experience of pharmaceutical microbiology. The applicant will be educated to degree level in a relevant subject or significant experience of working in a laboratory at a similar level or in a similar role. Applicant will need to demonstrate excellent communication and computer skills in addition to working with a team of microbiologists.

To download the job description please click here

PBL618 QC First Line Manager

Salary: Circa £36000.00 per annum plus 7% shift allowance

Reference Number: PBL618

The post holder will be required to work a shift rotation to support the manufacturing department. This shift rotation includes working late 2 weeks out of 8 weeks and with the potential of some weekend working. This shift rotation is inclusive of a 7% shift allowance.

See Job Description for full details;

Key responsibilities

    • Ensure the QC Analytical Services Laboratory operates in compliance with Porton Biopharma’s safety policy and cGMP.
    • Manage and lead the QC Analytical Services Laboratory to ensure the manufacturing deadlines are met.
    • Responsible for staff recruitment, appraisals and management to ‘Policies and Procedures’ documents. Planning of QC staff work schedules, resource management and costing work programmes.
    • Train QC staff within the QC Analytical Services Department in Procedures and Quality Management Systems to GMP requirements. Assist QC staff within QC Analytical Services Department with their ongoing development to aid their career and personal progression.
    • Manage and Track Compliance records for the QC Analytical Services Department, identify weaknesses, develop and implement improvements.

 Person Specification

  • Have current right to work in the UK;
  • Must have experience of managing and leading a team and extensive knowledge of analytical/biochemical techniques within a cGMP laboratory environment.
  • Must have extensive knowledge of developing analytical methods, method transfer, equipment introduction and validation lifecycle.
  • Must have experience of the out of specification process and carrying out laboratory investigations.
  • Must have extensive knowledge of compliance records and quality management systems within the pharmaceutical industry.
  • Clear communicator with excellent report writing and presentation skills
  • Be able to work to tight deadlines and the changing priorities to suit the needs of the business

To download the job description please click here

PBL643 Senior Microbiologist (Compliance)

Salary: Circa £27,000 per annum, dependant on experience

Reference Number: PBL643

The successful candidate will be joining the QC Microbiology department who are responsible for the Quality Control and Environmental Monitoring to support the manufacture of Erwinase and Anthrax Vaccine. The purpose of this role is to provide support for the QC Microbiology department at Porton Biopharma. This will include compilation of compliance documentation, including writing deviations, non-conformances and CAPA, change controls, protocols and reports. The holder will also to undertake and perform microbiological QC analyses in compliance with cGMP.

Key responsibilities

  • Operate in compliance in GMP and quality systems
  • Write and review Standard Operating Procedures, protocols and reports in accordance with regulatory requirements.
  • Investigate, write and review non-conformances and deviations raised in accordance with regulatory requirements.
  • Complete departmental CAPAs and to implement any required quality improvements that may arise from this.
  • Identify and implement quality improvements within the department pro-actively.
  • Carry out change management, raising, writing and reviewing change controls.
  • Assist as a member of the QC Microbiology Team, on a day to day basis.
  • Test microbiological samples, working at ACDP Containment level 2 and at Containment Level 3, when required, from all stages of the production processes of products manufactured at PBL, Porton Down and to assess the results against pre-set standards.
  • Record and assess results from environmental and water sampling and carry out preliminary and confirmatory identification of micro-organisms.

 Person Specification

  • Have current right to work in the UK;
  • We are looking for A candidate with significant experience of working to cGMP, with a significant knowledge of pharmaceutical Quality Assurance. The candidate must have experience in writing and reviewing discrepancies, procedures, change controls and CAPAs. The candidate should have a significant level of experience of working within ACDP containment level 2 microbiology laboratories.

 

To download the job description please click here

PBL617 Senior QC Analyst

Salary: Circa £28,500.00, per annum, dependant on experience

Reference Number: PBL617

An exciting opportunity has arisen for a Senior QC Analyst (Raw Materials) to join Porton Biopharma, a leading biopharmaceuticals company located on the historic Porton Down site, in the picturesque

The successful candidate will be joining the Analytical Quality Control Division, who are responsible for performing chemical and biochemical testing to ensure that the manufactured product is safe, efficacious and fit for patient use as a pharmaceutical material. As a Senior QC Analyst (Raw Materials) for Porton Biopharma, the post holder will undertake and supervise chemical and biochemical analyses to support the manufacture of Porton Biopharma’s licensed pharmaceutical products. Furthermore, will be responsible for supervising, scheduling and verifying work for QC Analysts primarily Raw Materials based, writing quality documentation relating to Raw Materials release and ensure that work performed within the laboratories is carried out in compliance with corporate statutory health and safety requirements.

The post holder will be required to work shift rotation. This rotation includes 2 weeks out of 8 weeks where the shift is 2-10pm and potential weekend working (schedule dependent).

Key responsibilities

  • Supervise and run day to day activities of the Raw Materials Testing Team within Quality Control Analytical;
  • Run Biochemical assays, enzyme kinetics and analysis as per the EP/USP;
  • Complete investigations and laboratory improvements;
  • Training members of the team will also be a crucial part of thee role.

Person Specification

  • Have current right to work in the UK;
  • Degree in Chemistry/Biochemistry, or similar degree, or suitable equivalent experience;
  • Knowledge/experience of the EP and USP;
  • Previous experience of working within a laboratory as and analyst, following written instructions and comparing analytical results with set specifications;
  • Experience with the out of specification process and carrying out laboratory investigations;
  • Self-motivated, with attention to detail and good time management;
  • Experience in supervising a team of QC Analysts and Technicians;
  • Must have working knowledge / experience of cGMP in a laboratory environment;
  • Must have experience of standard laboratory equipment and methods;
  • Knowledge and experience in chemical analysis is desirable.

To download the job description please click here

PBL616 Head of QA

Salary: Circa £75,000.00 per annum, dependant on experience

Reference Number: PBL616

Key responsibilities

  • Lead the QMS & Compliance teams to deliver compliant Quality systems, and develop a world-class QMS;
  • Provide operational direction and leadership to a large team of GMP Quality professionals, Documentation control, & Archivist staff;
  • Develop and manage the QA, GMP, & QMS programmes, policies, standards, and procedures to ensure conformance to the highest standards and regulatory agency requirements (MHRA, EU, FDA etc.);
  • Establish processes and systems that support collaboration, compliance and are simple and effective;
  • Lead and support where required with regulatory inspections;
  • Further develop, implement and manage processes that align with, and drive, effective systems for change control, deviations and investigations, complaints, recalls, risk management and CAPA;
  • Oversee GMP Quality system performance metrics, analyse compliance data and coordinate the necessary Quality reporting and escalation responses;
  • Manage the processes for the Quality Management Review Board, Change Control Review Board and Risk Management forums;
  • Provide expertise and guidance to senior management in the interpretation of global GMP regulations, ICH guidelines and internal policies and procedures;
  • Promote continuous improvements in quality systems and department infrastructure; assist with creation/revision of appropriate SOPs, Code of Practices, Policies & Key Quality documents;
  • Train, manage, and mentor QMS, GMP, & QA staff for the effective performance in PBL cGMP processes & compliance activities.

Person Specification

  • Have current right to work in the UK;
  • Experience managing in a successful business;
  • Proven Leadership and Management skills in a matrix management environment;
  • Practical understanding and working knowledge of GMP regulations and Compliance requirements, with the ability to provide applicable guidance;
  • Extensive experience in the pharmaceutical or biotech industry, with extensive GMP QA experience within the FDA and/or EMA regulated environment;
  • Demonstrable experience of GMP QA management of a team of QA Professionals;
  • Comprehensive working knowledge of local, state, federal and international cGMP regulations; FDA/EU/ICH guidelines; validation standards, QMS and quality risk management principles;
  • Proven experience with leading and hosting successful regulatory audits;
  • Ability to resolve complex problems where analysis of situations or data requires an in-depth evaluation of various factors;
  • Self-motivated and able to prioritize projects in a fast-paced environment.

To download the job description please click here

PBL610 Production Technician (PPC 5-8)

Salary: Circa £20,200.00 per annum dependant on experience

Reference Number: PBL610

The successful candidate will be joining the Production Support Unit, who are responsible the preparation, of equipment and reagents used during filling, freeze drying and finishing of pharmaceutical products. Working in a highly regulated environment, you will be working in a small team involved in the production of pharmaceutical products and the operation of production equipment used in the preparation of components. As a Production Technician for Porton Biopharma, the post holder will report to the Production Supervisor and will support the Production Supervisor to meet team targets by ensuring manufacturing operations are performed in a timely and compliant manner to cGMP requirements. This role will involve undertaking a varied range of tasks, from preparation and use of operational equipment to preparation, completion, and review of Quality documentation. Full training will be provided.

Key responsibilities

  • Be able to organise and perform, when applicable, activities relating to the cGMP manufacturing of pharmaceutical products, i.e. prepare media, buffers and reagents, both sterile and non-sterile.
  • Day to day tasks also include maintaining the facility via specialist cleaning procedures, monitoring environmental conditions and performing aseptic processes within a cleanroom environment.
  • Ensure that their daily activities are coordinated with other team members.
  • Work within a GMP quality system.
  • Ensure that documentation is completed within the legal frameworks.

 Person Specification

  • Have current right to work in the UK;
  • GCSE’s in in Maths, English and Science or equivalent qualifications

To download the job description please click here

PBL600 Senior Production Technician (FPP)

Salary: £20,500.00 gross per annum, plus 30% shift allowance

Reference Number: PBL600

The successful candidate will be joining the Production Division as a Senior Production Technician for Porton Biopharma. This is a shift working role which will attract a salary enhancement once appointed. This Senior Production Technician post is located at Porton Down in the Fermentation Process Plant (FPP) current Good Manufacturing Practice (cGMP) pharmaceutical manufacturing facility. This facility produces therapeutic products by bacterial fermentation followed by initial phase downstream processing. Therapeutic products produced at Porton are licensed and marketed for worldwide distribution. The FPP is undergoing significant investment and expansion as production is being increased to meet product demand.

Candidates should have an interest in working within a manufacturing environment and with the Quality systems associated with cGMP manufacture. They should be able to communicate clearly, possessing good writing and data entry skills. Lastly applicants should be able to work effectively as part of a team, be proactive and able to work on their own initiative when required.

The successful candidate will work a shift pattern which covers 24-hour, 7 days working. They will report to the Production Supervisor and will support the Production Supervisor to meet team targets by ensuring manufacturing operations are performed in a timely and compliant manner to cGMP requirements. This role will involve undertaking a varied range of tasks, from preparation and use of operational equipment such as large-scale fermenters and centrifuges, to preparation, completion, and review of Quality documentation. Full training will be provided.

Key responsibilities

  • Working in an automated chemical plant.
  • Operate plant and equipment using newly installed automated control systems.
  • Ensure that the various work areas are maintained at the highest state of readiness at all times.
  • Ensure that their daily activities are coordinated with other team members.
  • Work within a GMP quality system.
  • Ensure that documentation is completed within the legal frameworks.
  • Take responsibility for Non-Conformances, CAPA, Risk Assessments and Change Controls for the area and ensure SOPs and BMRs are available for use.

Person Specification

  • Have current right to work in the UK;
  • GCSE’s in in Maths, English and Science or equivalent qualifications
  • A minimum of NVQ level 2 in a relevant subject or have significant equivalent proven experience
  • Worked within a manufacturing environment and with the Quality systems associated with cGMP manufacture.
  • Successful applicants must either hold, or be capable of obtaining, a UK government security clearance at SC level.  To obtain clearance at this level you must have been resident in the UK for the last five years, and not lived abroad for more than six months out of the last twelve.

To download the job description please click here

PBL599 QC Analyst

Salary: Circa £24,000.00 DOA with 7% shift allowance

Reference Number: PBL599

The successful candidate will be joining the QC Analytical team who are responsible for performing chemical and biochemical testing to ensure that the manufactured product is safe, efficacious and fit for patient use as a pharmaceutical material. As a QC Analytical for Porton Biopharma, the post holder will responsible for testing of in process and finished product samples, to defined specifications, while ensuring that work performed within the laboratories is carried out in accordance with the statutory requirements of current GMP and corporate statutory health and safety requirements.

The post holder will be required to work shift rotation. This rotation includes 2 weeks out of 8 weeks where the shift is 2-10pm and potential weekend working (schedule dependent).

Key responsibilities

  • To ensure analysis and recording of QC and stability testing is performed in compliance with the statutory requirements of cGMP.
  • Responsible for testing raw materials, in process and finished product samples to ensure that they meet the specifications established in the product licence and internal Porton Biopharma specification documents.
  • Responsible for writing Standard Operating Procedures and their associated risk assessments to ensure that those tasks are performed safely.
  • Write quality documents e.g. change controls, validation reports, non-conformances and CAPA’s where appropriate.
  • Organise and liaise with internal departments such as validation, pharms stores and QA where required.
  • Undertake work in accordance with Porton Biopharma’s Code of Safety Practice and Quality Systems.
  • Maintain training records.
  • Cleaning of laboratories.
  • Maintenance and calibration of equipment.

Person Specification

  • Have current right to work in the UK;
  • Degree or equivalent qualification in Chemistry/Biochemistry or other related subject or previous relevant experience.
  • Working knowledge/ Experience of cGMP
  • Working knowledge/ Experience of the EP and USP
  • Previous experience of working in a similar position as a bench analyst following written instructions and comparing analytical results with set specifications
  • Experience using standard analytical laboratory equipment such as pH meters, balances, pipettes
  • Good basic computer stills and literacy

 

 

To download the job description please click here

PBL588 Senior Production Technician - PPC 1-4

Salary: £20,500.00 gross per annum

Reference Number: PBL588

The successful candidate will be joining the PPC Team in Production who are responsible duties including media and equipment preparation, assisting with purification and formulation of Erwinase drug substance, sterile filtration, and aseptic processing. The team is responsible for the production of pharmaceutical products, preparation of components and the operation of production equipment. Day to day tasks also include maintaining the facility via specialist cleaning procedures and monitoring environmental conditions within a cleanroom environment.

As a Senior Production Technician for Porton Biopharma, the post holder will the post holder will report to the Production Supervisors, and the Unit Team Leader. He/she will support the Production Supervisors to meet team targets by ensuring manufacturing operations are performed in a timely and compliant manner to cGMP requirements. This role will involve undertaking a varied range of tasks, from preparation and use of operational equipment, to completion of Quality documentation. Full training will be given where required

Key responsibilities

  • Be responsible to the Unit Supervisor for your day to day activities.
  • Undertake all work in accordance with Code of Safety Practice, Quality System and all other regulatory requirements.
  • Follow all Procedures, Policies, Rules, Regulations and Guidelines for all activities to ensure products meet the required standard.
  • Always take care and pay detailed attention to all tasks. Complete documentation and records accurately and to a high standard.
  • Work to cGMP ensuring the unit is maintained in a compliant state following Standard Operating Procedures (SOPs) and codes of practice. Keep updated on new rules and regulations.
  • Maintain production areas to the required standard using defined cleaning procedures.
  • Perform and record environmental monitoring in cGMP areas in accordance with documented procedures. Take waters samples and complete relevant documentation. Monitor and record air pressures and hot and cold facility temperatures.
  • Support junior staff in their activities and ensure they are adequately trained in all operational processes required.
  • Be responsible to the Unit Supervisor for the day to day operations of the Unit and, if required, to deputise in their absence.
  • Undertake all work in accordance with the Code of Safety Practice, Quality System and all other regulatory requirements.
  • Follow all Procedures, Policies, Rules, Regulations and Guidelines for all activities to ensure products meet the required standard.
  • Generate documentation with regard to risk assessments and cGMP to ensure compliance of the Unit with all necessary regulations.
  • Complete documentation and records accurately and to a high standard.
  • Work to cGMP ensuring the unit is maintained in a compliant state following Standard Operating Procedures (SOP’s) and codes of practice. Keep updated on new rules and regulations.
  • Maintain production areas to the required standard using defined cleaning procedures.
  • Perform and record environmental monitoring in cGMP areas in accordance with documented procedures. Take waters samples and complete relevant documentation. Monitor and record air pressures and hot and cold facility temperatures.
  • Analyse information and make decisions based on assessment.
  • Execute Validation Protocols on equipment.
  • Perform a wide range of routine and some non-routine technical procedures and understand the rationale behind the procedures and practices.
  • Maintain and use a variety of specialised equipment.

Person Specification

  • Have current right to work in the UK;
  • GCSE in Maths, English and Science or equivalent qualifications. In addition, applicants should be educated to a minimum of NVQ level 2 in a relevant subject or have significant equivalent proven experience
  • Have an interest in working within a manufacturing environment and with the Quality systems associated with cGMP manufacture
  • be able to communicate clearly, possessing good writing and data entry skills.
  • a flexible approach to work, be able to work effectively as part of a team, and be proactive and able to work on their own initiative when required

To download the job description please click here

PBL582 QC First Line Manager (Compliance)

Salary: Circa £36000.00 per annum, dependant on experience

Reference Number: PBL582

Key responsibilities

  • To operate in compliance with cGMP, USP, EP, BP, JP, In-house, FDA and MHRA regulatory requirements, including management of one of the QC Microbiology Units facilities and equipment.
  • To manage, lead and motivate one of the QC Microbiology Units in the planning, resource management, direction and performance of specialist microbiological analyses and testing to regulatory/customer requirements to support pharmaceutical manufacture.
  • To recognise and play a lead role with internal and external customers in the development of novel microbiological techniques in support of project requirements, regulatory requirements and business needs.
  • To support PBL, Porton Down in performance of validation programmes to meet regulatory/customer requirements.
  • To take and maintain a lead role in the preparation, approval and maintenance of procedures, protocols and reports in accordance with customer requirements and regulatory needs. 

Person Specification

  • Have current right to work in the UK;
  • Degree in a scientific discipline
  • GMP Experience or similar regulated environment
  • Experience and knowledge of environmental monitoring
  • Cleanroom and Lab experience
  • Experience of Aseptic Manufacture, practices, microbiology, hygiene and contamination control
  • Managerial skills

To download the job description please click here