Careers

Porton Biopharma has approximately 350 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.

 

 

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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
  • a canteen, gym and an active sports & social club
  • 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 applications should be sent to recruitment@portonbiopharma.com.

WORK EXPERIENCE

As a business, we recognise the value that offering work-experience placements can bring and typically offer up to 4  one-week placements each year, usually in June.   All applicants must be over 16 years of age at the time of the placement, and will be chosen following a selection process.

If you are interested in applying, then send an email and covering letter stating your interest and giving reasons why we should choose you to business@portonbiopharma.com  Applications must be received by the end of November in order to be considered for the following summer’s places.

 

PBL566 Commercial Development and Alliance Manager

Salary: Circa £42,200 gross per annum

Closing Date: 31st January 2020

Reference Number: PBL564

Job summary…

The Alliance Manager position is a brand new and critical role in supporting the day to day management of PBL accounts. The job holder will join at an exciting time with an ever-increasing demand for our products on a global basis. With this increase there is a need for comprehensive external management of our clients, thorough internal coordination as well as an ability to source new opportunities.

The post holder will

  • Be accountable for managing and optimizing a portfolio of selected global alliances as well as development of collaborative capabilities both in the private UK public sector.
  • Be responsible for the overall execution of alliances under the direction and guidance of the Director of Commercial and act as intermediary between the partners.
  • Be responsible for the activities related to alliance processes, governance procedures, alliance analysis frameworks, metrics, reporting, organisational training and external promotion of alliances.
  • Be accountable for proactively and strategically managing established and new alliance relationships.
  • Be required to proactively identify and mitigate issues at the appropriate level of partnership management and ensure proper governance of the alliance.
  • Lead Strategic alliance budget, performance monitoring and planning.
  • Support new alliances and ensure a smooth transition and implementation post contract signature by leading the alliance launch process.
  • Be a key driver of the goals of the collaboration and manage the long-term relationships between PBL and their partners by acting as the key-interface with respect to the management of the legal and contractual framework established for the alliances
  • Represent the Strategic Alliance Management team within relevant global franchises and work directly with stakeholder functions
  • Communicating deliverables and partners’ related obligations to senior management and ensuring that contractual obligations are met on time and in alignment with PBL’s interests

We are looking for…

A senior manager with strong leadership skills who has significant experience in alliance management, operational management or strategic marketing from a global biotech or medium-sized pharma Company. The successful candidate will have an understanding of pharmaceutical science, due diligence, finance and alliance management. They will also have excellent interpersonal skills and be able to demonstrate strong networking, relationship management and negotiation skills.

To apply for this position please submit a CV and cover letter using the criteria in the job description/person specification as sub-headings to identify how you meet each of the selection criteria and outline why you would like a career at Porton Biopharma Ltd.

Porton Biopharma Ltd promotes diversity in the workplace and is an equal opportunities employer

 

To download the job description please click here

PBL486 Environmental Monitoring Compliance Officer

Salary: Circa £28,000 per annum, dependant on experience

Closing Date: 31st January 2020

Reference Number: PBL486

Job Summary………………..

The purpose of this role is to provide support for the Sterility Assurance Program at Porton Biopharma. This will include compilation of environmental monitoring trend reports, managing GMP databases and preparing technical reports. The applicant will be taking a leading role in SOP review, developing sampling programs, leading investigations and providing technical support as required.

We are looking for……………….

Someone with GMP experience of working in cleanrooms, developing environmental monitoring programs through a risk based approach and giving technical support in investigations. The candidate should have a good understanding of QC Microbiology laboratory testing, EM and Water testing, working with computer databases and be competent in programs such as MS Excel. Applicants must have a flexible approach to working and be able to comply with SAPO regulations.

The post holder will……………...

  • To assist as a member of the QC Environmental Monitoring Team effectively to achieve the team objectives
  • To liaise with internal customers, production staff, operational project management, and other quality staff to promote compliance with GMP and customer requirements and act as a Subject Matter Expert during regulatory and customer audits.
  • To co-ordinate and review water quality, clean steam quality, and microbiological and non-viable environmental monitoring activities, as required.       To prepare trend analysis data as graphs, charts and / or diagrams as required.
  • To investigate out-of-specification water and environmental monitoring test results in conjunction with the Compliance Team and review resulting Non-Conformances, participating in Ishikawa and 5-Whys investigations, where necessary.
  • To be a member of the Environmental Monitoring Team, Sterility Assurance Program Board and Water Quality Group, attending meetings and completion of actions as required.
  • To generate the water monitoring schedule.
  • To review and process, where required, CAPAs, Change Controls, Validation Documentation, GMP Engineering testing reports and sign off as QC reviewer, where applicable.
  • To prepare environmental summary reports and Product Quality Reviews of production processes for insertion into documents, reports and batch manufacturing records as part of batch release.
  • To review the environmental monitoring SOPs for each production area in conjunction with QA and Production.
  • To participate in facility release and other internal and external audits, as required.
  • To review facility, utility and equipment documentation, monitoring data and validation / calibration data and review summary reports for facility release purposes.
  • To carry out smoke visualisation testing as part of a multidisciplinary team including members of QA, Production and GMP Engineering in order to identify appropriate environmental monitoring sites.
  • To carry out oversight duties in manufacturing areas, record findings and communicate to the Line Manager and QA.
  • To undertake relevant training.
  • To undertake work in accordance with the PBL’s Health and Safety policies and procedures and to work within any Quality Systems that are applicable to the site.
  • To comply with PBL policies and procedures.

For further information or an informal discussion about the post, please contact: Richard Tyrrell: Richard.Tyrrell@portonbiopharma.com

To apply for this position please submit a CV and cover letter using the criteria in the job description/person specification as sub-headings to identify how you meet each of the selection criteria and outline why you would like a career at Porton Biopharma Ltd.

Porton Biopharma Ltd promotes diversity in the workplace and is an equal opportunities employer

To download the job description please click here

PBL407 Process Engineer

Salary: Circa £40,000 per annum

Reference Number: PBL407

Job Summary…

The Engineering group provides all engineering support within the highly regulated GMP production facilities at PBL Porton Down. The group includes engineering functions provided by predominantly chartered professional engineers specialising in clean rooms, GMP critical utilities, production equipment, pharmaceutical facilities, and capital works delivery.

The Process Engineer is the System technical expert for all Process and Utility systems within the GMP Envelope and is responsible for identification of and managing small projects/initiatives relating to these systems and interfacing with the wider Engineering group to ensure equipment systems within the GMP envelope remain compliant with current Good Manufacturing Practice. In addition, the Process Engineer will work within an Integrated Process Team to provide operational support to the manufacture of biopharmaceutical products.

The post holder will…

Be a core member of an Integrated Process Team and will provide operational engineering support to the manufacture of biopharmaceutical products alongside other core members from the Production and Quality functions. You will have delegated responsibility from the Process Engineering Manager to design, manage and deliver process improvement projects and represent the group in the delivery of major facility expansion/refurbishment projects.

You will become the Subject Matter Expert for a variety of systems and equipment such as Autoclaves and Critical Utilities (e.g. WFI, Clean Steam, and Purified Water) within the Pharmaceutical Production Envelope. As such you will interface with key stakeholders including equipment users, capital project managers, and the site principal maintenance contractor, to ensure these critical systems remain in compliance with best industry and regulatory practice.

We are looking for…

An applicant with experience of design or operation of process or utility systems in a highly regulated industry. The ideal candidate will have existing experience in the pharmaceutical industry. The individual will be either working towards or have recently become chartered with a supporting process or chemical engineering degree.

To download the job description please click here

PBL411 Aseptic Processing Specialist

Salary: Starting salary £29,355 negotiable dependent upon experience

Reference Number: PBL411

Job Purpose…

This position will report to the Aseptic Processing Functional Manager and will provide technical specialist support to all aseptic processing activities in the manufacture of Erwinase, Anthrax vaccine and other PBL products. The role will work cross functionally and be involved in current projects, new projects and all manufacturing activities that require aseptic processing input. It is expected that the role will typically focus on day to day aseptic processing matters within Production but may also be required to support projects designed to improve and develop PBL’s aseptic processing strategy.

We are looking for…

An individual who is educated to degree level or equivalent in a relevant discipline. The successful candidate should have a minimum of 5 years’ experience within Biopharma / Pharma aseptic GMP environments and have an in depth understanding of aseptic processing and techniques. You will need to have an understanding of regulatory requirements for biological products and experience in the implementation of new technologies and equipment into GMP manufacture and will have proven experience of generating GMP documents within a quality system. Experience of delivering specialised technical training and report writing and data trending evaluation would be desirable but not essential. The successful applicant will have a flexible approach to work and be able to deliver to schedules.

The post holder will…

  • Lead in the day to day aseptic processing of PPL’s products.
  • Support the management and development of improved and new processing techniques in the various aseptic processing activities.
  • Provide technical support to production staff involved in the various aseptic processes.
  • Provide troubleshooting and technical support into process investigations.
  • Collate and share technical information with internal and external bodies to benefit the production methods, teams and departments.
  • Perform process mapping and process efficiency trending.
  • Provide specialist training to staff in aseptic processing techniques and theory.
  • 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.
  • Assist colleagues in providing technical specialist input as required, in developing production and technical strategies for the units, identifying new opportunities as they arise and responding to external queries and complaints.
  • Contribute to reports and assist on the preparation of presentations, publications and liaison with customers, collaborators and licensing agencies.
  • Support the Functional Manager Aseptic Processing in pursuance of strategic improvements to aseptic processing control.

To apply for this position please submit a CV and cover letter using the criteria in the job description/person specification as sub-headings to identify how you meet each of the selection criteria and outline why you would like a career at Porton Biopharma Ltd.

Porton Biopharma Ltd promotes diversity in the workplace and is an equal opportunities employer

We reserve the right to close this vacancy should a suitable candidate be found.

To download the job description please click here

PBL442 Computer System Validation Specialist

Salary: Starting salary £42,230 negotiable dependent upon experience

Reference Number: PBL442

Job Purpose

This role is within the Facilities Validation Department and is responsible for the provision of subject matter expertise and the execution of Computerised System Validation activities.The Facilities Validation department supports cGMP manufacturing activities and is responsible for ensuring compliance to the cGMP guidelines.

This role reports into the Computer Systems Validation Manager and is responsible for the timely execution of Computer Systems Validation activities with respect to:

  • Writing (and reviewing) of validation protocols
  • Timely execution of CSV protocols with the subsequent generation of reports
  • Leading CSV compliance investigations with respect to Non-conformances and CAPAs
  • Performing CSV / Data integrity gap analysis and remediation activities.

The post holder will be expected to write, review and approve validation protocols, execute validation studies and write, approve validation reports associated with the qualification of Computerised systems and the introduction of new equipment into beneficial use.

The post holder will…

  • 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.
  • Promote 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
  • Provide a reliable service to our internal customers to ensure that timescales are met, and work is carried out to meet expectations.
  • Maintain the ongoing compliant status of computer systems associated with equipment, facilities and utilities by involvement of the scheduling of activities.
  • Communicate validation activities with our internal and external customers and work 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.

We are looking for…

The successful candidate will be educated to BTEC National Certificate level including Science or equivalent qualification or significant equivalent experience. A BSc in Engineering, Science or IT would be desirable but is not essential. You will need to have substantial experience of generation, execution and review of validation protocols, reports and technical documents as well as experience of validation life-cycle activities for computerised systems. The successful applicant will have extensive practical experience of working within a GMP quality system. Practical experience of working within a biopharmaceutical manufacturing environment would be desirable.

This is a hands-on role in a dynamic operating environment and the ideal candidate should be self-driven and capable of organising their own work-load. They should be comfortable liaising with stake-holders in order to deliver an effective documentation to an agreed time line and be confident to supervise junior staff.

For further information about the post, please contact: kevin.smart@portonbiopharma.com

To download the job description please click here

PBL485 QC Technologist (Monitoring and Training)

Salary: Starting salary £23,735 per annum negotiable dependent upon experience

Reference Number: PBL485

Job Purpose…

To provide specialist training in microbiological environmental monitoring methods, cleanroom gowning, aseptic practices and water sampling. The successful candidate will also be required to undertake microbiological environmental monitoring of critical pharmaceutical manufacturing operations to support the Sterility Assurance Program. To supervise, oversee, observe and qualify all production technologists and other staff where applicable, in gowning, microbiological environmental monitoring methods and water sampling.

We are looking for…

A candidate who has previous experience of working in cleanrooms, performing environmental monitoring and training of other members of staff to join the Environmental Monitoring Team within QC Biological Services. A degree in a relevant scientific discipline is desirable but not essential. The candidate should also have a good understanding of QC Microbiology laboratory testing. Applicants must have a flexible approach to working and be able to comply with SAPO regulations and must have a current valid right to work in the UK.

The post holder will…

  • Operate in compliance with cGMP.
  • Train and qualify all Production and other staff, as necessary, in the techniques and procedures for microbiological environmental monitoring.
  • Train and qualify all Production and other staff, as necessary, in water sampling.
  • Train and qualify all Production and other staff, as necessary, in procedures for gowning.
  • Oversee, supervise and observe Production and other staff undertaking environmental monitoring and water sampling to ensure continued compliance.
  • Re-qualify Production and other staff at a defined frequency, as required by GMP.
  • Plan and organise schedules for training, qualifications and observations.
  • Assess staff competence in environmental monitoring, water sampling and gowning procedures. Sign training documentation and produce certificates for trained members of staff.
  • Carry out and record microbiological environmental monitoring for critical manufacturing operations, and routine monitoring where required.
  • Input microbiological environmental monitoring and water sampling data into appropriate databases and spreadsheets.
  • Be involved in the writing and updating of Standard Operating Procedures relating to environmental monitoring and water sampling, either as the author, or by providing technical information and advice to the author.
  • Attend training courses that contribute to the efficiency of the operating systems and are beneficial to the post holder’s personal development.
  • Follow operating procedures at all times and ask for advice when necessary.
  • Undertake all work in accordance with Porton Down’s Code of Safety Practice and Quality Systems.
  • To prepare environmental summary reports of production processes for insertion into documents, reports and batch manufacturing records as part of batch release.
  • To investigate out-of-specification water and environmental monitoring test results in conjunction with the Compliance Team and review resulting Non-Conformances, participating in Ishikawa and 5-Whys investigations, where necessary.

For further information about the post, please contact:

recruitment@portonbiopharma.com

To apply for this position please submit a CV and cover letter using the criteria in the job description/person specification as sub-headings to identify how you meet each of the selection criteria and outline why you would like a career at Porton Biopharma Ltd.

Porton Biopharma Ltd promotes diversity in the workplace and is an equal opportunities employer.

We reserve the right to close this vacancy should a suitable candidate be found.

PBL498 Validation Technologist (Facilities & Utility)

Salary: Starting Salary £29,335 negotiable dependent upon experience.

Reference Number: PBL498

Job Purpose…

The Facilities Validation department supports cGMP manufacturing activities and is responsible for ensuring compliance to the cGMP guidelines on Validation activities.

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

The post holder may be expected to supervise contractor resource where appropriate with responsibility to ensure adequate training and supervision is provided.

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

  • Autoclaves (BSEN-285)
  • Depyrogenation ovens
  • Extraction Tanks
  • Centrifuges
  • Vessels
  • (but not limited to) the qualification of Facilities and Utilities.

The post holder will...

  • Generate, review (technical) and execute process validation protocols (thermal and microbiological testing)
  • Create Process validation reports
  • Use the Electronic Quality Management System (EQMS) to manage appropriate corrective action plans and report through the PBL non-conformance system, for failures/performance issues.
  • Write and review Risk assessments
  • Manage work schedule as planned by the validation schedule co-ordinator
  • Coordinate Contractor or permanent resources to deliver timely documentation in support of Process Validation activities
  • Ensure Process Validation procedures are aligned with regulatory requirements
  • Meet all internal regulatory training requirements (internal training provided)

We are looking for...

A person with at least 12 months hands-on validation experience, able to perform thermal mapping studies and write protocols and reports. A sound knowledge of the Validation Life cycle and documentation deliverables is an essential requirement.

Other
In addition to Utilities and Sterilisation validation activities the post holder will be expected to undertake any related validation activities deemed necessary by line management. This could include the generation of validation documentation in accordance with the full validation life cycle for equipment, utilities and facilities.

For further information or an informal discussion about the post, please contact:

recruitment@portonbiopharma.com

To apply for this position please submit a CV and cover letter using the criteria in the job description/person specification as sub-headings to identify how you meet each of the selection criteria and outline why you would like a career at Porton Biopharma Ltd.

Porton Biopharma Ltd promotes diversity in the workplace and is an equal opportunities employer.

We reserve the right to close this vacancy should a suitable candidate be found.

PBL508 QC Technologist

Salary: Circa £23,500 per annum, dependant on experience & 7% shift allowance

Reference Number: PBL508

Job Summary…

A crucial part of the pharmaceutical production process is undertaken by the Quality Control Department, which performs chemical and biochemical testing to ensure that the manufactured product is safe, efficacious and fit for patient use as a pharmaceutical material. The QC Technologist is primarily 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 QC Technologist is also responsible for the authoring of technical documentation and liaising with external laboratories to arrange contract testing of products.

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).

We are looking for…

The ideal candidate will be educated to degree level or equivalent qualification in Chemistry, Biochemistry or other related subject. The successful candidate will have working knowledge or experience within a regulated or Good Manufacturing Practice (GMP) environment. Experience in biopharmaceutical analysis and analytical chemistry is desirable in one of the following areas; Water analysis, TOC, physical testing, UV-Vis or pharmacopoeia testing within a GMP compliant QC laboratory. Other key skills include the ability to work to deadlines, technical report writing, problem solving, the ability to work as part of a project team and good computer literacy.

 The post holder will…

  • Ensure analysis and recording of QC and stability testing is performed in compliance with the statutory requirements of cGMP.
  • Be responsible for testing in process and finished product samples to ensure that they meet the specifications established in the product licence and internal Porton Biopharma specification documents.
  • Be responsible for writing Standard Operating Procedures and their associated risk assessments to ensure that those tasks are performed safely, and other quality documents e.g. change controls, validation reports, non-conformances and CAPAs where appropriate.
  • Organise and liaise with external testing laboratories to arrange correct and on time testing to meet production deadlines or suppliers of equipment or chemicals.
  • Organise and liaise with internal departments such as validation, pharms stores and QA where required.
  • Maintain an up-to-date awareness of regulatory and scientific developments via courses, meetings and literature.
  • Undertake work in accordance with Porton Biopharma’s Code of Safety Practice and Quality Systems.
  • Maintain training records.
  • Cleaning of laboratories.
  • Performing maintenance and calibration of equipment.

For further information about the post, please contact:

recruitment@portonbiopharma.com

To apply for this position please submit a CV and cover letter using the criteria in the job description/person specification as sub-headings to identify how you meet each of the selection criteria and outline why you would like a career at Porton Biopharma Ltd.

Porton Biopharma Ltd promotes diversity in the workplace and is an equal opportunities employer

To download the job description please click here

PBL509 Technical Support Specialist (Fermentation)

Salary: Circa £36,460 negotiable dependent upon experience

Reference Number: PBL509

Job Summary…

The Technical Support Specialist reports directly to the Technical Operations Manager. This position is a technical role primarily to support and improve the processes, policies, people and procedures associated with the manufacture of products at PBL. The Technical Support Specialist will have an excellent knowledge and significant experience in the field of fermentation and actively participate or lead in identifying and bringing into use new technologies, investigate and resolve technical issues, generate reports, protocols and other GxP documentation and provide technical input, advice and training as appropriate.

The post holder will…

  • Lead in the day to day fermentation processing of PBL’s products.
  • Support the management and development of improved and new processing techniques in the various fermentation processing activities.
  • Provide technical support to production staff involved in the various fermentation processes.
  • Provide troubleshooting and technical support into process investigations.
  • Collate and share technical information with internal and external bodies to benefit the production methods, teams and departments.
  • Perform process mapping and process efficiency trending.
  • Provide specialist training to staff in fermentation processing techniques and theory.
  • 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.
  • Assist colleagues in providing technical specialist input as required, in developing production and technical strategies for the units, identifying new opportunities as they arise and responding to external queries and complaints.
  • Contribute to reports and assist on the preparation of presentations, publications and liaison with customers, collaborators and licensing agencies.
  • Support the Unit Manager in pursuance of strategic improvements to processing control.

We are looking for…

 An individual with significant relevant fermentation experience and proven practical experience of working within a fast-moving Good Manufacturing Practices (GMP) environment. The role will require the individual to have an understanding of regulatory requirements for biological products and have specific training and experience in fermentation production methods in a pharmaceutical environment. The successful candidate will be highly flexible and capable of managing several activities simultaneously, have excellent problem solving skills, strong technical writing ability, project management and hands on experience of Fermentation and Aseptic processes are essential.

For further information or an informal discussion about the post, please contact:

recruitment@portonbiopharma.com

To apply for this position please submit a CV and cover letter using the criteria in the job description/person specification as sub-headings to identify how you meet each of the selection criteria and outline why you would like a career at Porton Biopharma Ltd.

Porton Biopharma Ltd promotes diversity in the workplace and is an equal opportunities employer

To download the job description please click here

PBL522 Senior Production Technician - FPP - 2 Year Fixed Term Contract

Salary: Starting salary £21,000 per annum, plus 30% shift enhancement

Reference Number: PBL522

Job Purpose…

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.

We are looking for…

An applicant who has GCSE’s in Maths, English and Science or equivalent qualifications. In addition, they should also be educated to a minimum of NVQ level 2 in a relevant subject or have significant equivalent proven experience. 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 post holder will…

Work a shift pattern which covers 24-hour, 7 day 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.

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.

For further information about the post, please contact: recruitment@portonbiopharma.com

Applicants are strongly advised to use the criteria in the job description/person specification as sub-headings in their application to make it clear how they meet each of the selection criteria.

Porton Biopharma Ltd promotes diversity in the workplace and is an equal opportunities employer

To download the job description please click here

PBL539 QC Microbiology Technologist

Salary: Circa £23,500 per annum, negotiable dependant on experience

Reference Number: PBL539

Job Purpose…

The post holder will be part of the QC Bacteriology Technical Services team and assist with activities which include the following:

To undertake and perform microbiological QC analyses in the Quality Control Bacteriology Technical Services Unit, which provides specialist microbiological testing services in support of licensed pharmaceutical manufacture at PBL, Porton Down, in compliance with cGMP.

The post holder will…

  • 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
  • Record all information and data clearly and accurately
  • Pre-test media used within QC and Production against pre-set specifications
  • Maintain the Bacteriology Technical Services Culture Collection, media stocks, and necessary consumables to ensure the efficient running of the group
  • Safely operate, clean and maintain laboratory equipment to the required levels of cleanliness and operating standards
  • Provide cover for and assist the Environmental Monitoring team when required

 We are looking for…

An applicant who has good interpersonal skills, is able to work as part of a team and is methodical and reliable with the ability to think clearly. The successful applicant will have the ability to learn and be able to respond to changes in schedule and demands. They will need to have knowledge and experience of microbiology gained in a laboratory or similar environment and ideally have experience of working in a Good Manufacturing Practice (GMP) or similarly regulated environment.

 

Key skills are:

  • 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 apply for this position please submit a CV and cover letter using the criteria in the job description/person specification as sub-headings to identify how you meet each of the selection criteria and outline why you would like a career at Porton Biopharma Ltd.

Porton Biopharma Ltd promotes diversity in the workplace and is an equal opportunities employer

To download the job description please click here

PBL558 Senior QC Technologist (Fixed Term 12 month)

Salary: Circa £25,000 negotiable dependant on experience

Reference Number: PBL558

Job Summary...…….

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 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.

The post holder will…………

  • To review data produced within the QC Microbiology department and ensure compliance with GDP and regulatory requirements.
  • To write and review Standard Operating Procedures, protocols and reports in accordance with regulatory requirements.
  • To aid in departmental CAPAs and to implement any required quality improvements that may arise from this.
  • Identify and implement quality improvements within the department pro-actively.
  • To assist as a member of the QC Microbiology Team, on a day to day basis, of the Bacteriology Technical Services Unit.
  • To record and assess results from environmental and water sampling and carry out preliminary and confirmatory identification of micro-organisms.
  • To record test results clearly and accurately and perform calculations as required and to check and sign–off colleague’s results and calculations.
  • To safely operate, clean and maintain highly complex equipment to the required levels of cleanliness and operating standards and to record all such operations and maintenance.

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 reviewing procedures, GMP documentation and data entry. The candidate should have a significant level of experience of working within ACDP containment level 2 microbiology laboratories.

To apply for this position please submit a CV and cover letter using the criteria in the job description/person specification as sub-headings to identify how you meet each of the selection criteria and outline why you would like a career at Porton Biopharma Ltd.

Porton Biopharma Ltd promotes diversity in the workplace and is an equal opportunities employer

PBL560 Transport Validation Specialist

Salary: Circa £45,000 per annum

Reference Number: PBL560

Job Summary…

The role of the Transport Validation Specialist is to co-ordinate and execute the timely completion of transport validation studies in support of PBL product and sample shipment activities and regulatory requirements.A knowledge of Validation Life Cycle documentation deliverables and how to implement a risk based approach is central to the skills base of this position.The role will include the writing, review and execution of transport validation protocol documents and reports, plus the coordination of support activities and resources to deliver on time a high standard of validation activity.The post holder will be expected to attend project group meetings, liaise with PBL support teams and peers to establish data for inclusion within protocols and reports.The position holder should be prepared to execute and witness transport validation studies in line with PBL requirements.There will be a requirement to support other validation activities (e.g. Equipment Validation) on a temporary basis.

The following is a description of the main duties and responsibilities;

  1. Carry out transport validation gap analysis of current routes
  2. Write transport validation plans
  3. Write, review and execute transport validation protocols
  4. Write transport validation reports
  5. Deliver assigned equipment and utility/facility validation activities on time in accordance with the Site Validation Master Plan (VMP)
  6. To deliver on non-conformance, action item, change control (CC) and CC actions on time
  7. Participate in assigned project meetings/activities, as required
  8. To support operational areas in the implementation of change
  9. High level of technical and scientific writing required
  10. Ensure the timely completion of Deviations and the closure of CAPAs

We are looking for…

Essential

  • Degree or equivalent higher education qualifications in a science or engineering discipline.
  • Experience within the pharmaceutical or biopharma industry.
  • Experience within a Transport Validation role.
  • Experience within other aspects of validation.
  • Understanding of the Validation Life Cycle.
  • Demonstrated skills and capability in planning, preparing, executing and reporting of validation activities.
  • Good computer skills: Word, Excel.

Desirable

  • Project Management experience.
  • Management of internal customer expectations.
  • Cross functional communication skills.
  • Awareness of the risk-based approach to validation.

To apply for this position please submit a CV and cover letter using the criteria in the job description/person specification as sub-headings to identify how you meet each of the selection criteria and outline why you would like a career at Porton Biopharma Ltd.

Porton Biopharma Ltd promotes diversity in the workplace and is an equal opportunities employer

To download the job description please click here

PBL561 Master Control System Administrator and System Improvement Specialist

Salary: Circa £29,335, dependant on experience

Closing Date: 24th January 2020

Reference Number: PBL561

Job Summary:

The role is intended to perform the identification and implementation of improvements to processes associated with PBL’s eQMS – Master Control including:

  • System configuration changes
  • Alteration of existing work processes.
  • Administration of Users
  • Training of Users
  • Implementation of additional functionality (modules or forms based processes)
  • Streamlining and modification of existing processes to introduce improvements

The role will also drive periodic system upgrades to minimize system downtime including:

  • software platform upgrades
  • hardware changes
  • review of IT systems patches

 The post holder will:

Identify and drive implementation of beneficial changes to PBL’s eQMS, including introduction of new modules / work packages, generation of automated forms, and configuration changes. 

We are looking for:

An applicant with IT skills and previous experience of development, implementation of improvements and the routine administration of computerised systems used for inputting, storing and disseminating information.

Previous experience of working within a pharmaceutical environment, operating within the requirements of the Quality System and to GxP requirements is required.

 To apply for this position please submit a CV and cover letter using the criteria in the job description/person specification as sub-headings to identify how you meet each of the selection criteria and outline why you would like a career at Porton Biopharma Ltd.

Porton Biopharma Ltd promotes diversity in the workplace and is an equal opportunities employer

To download the job description please click here

PBL562 QC Microbiology Laboratory Manager (First Line Manager)

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

Closing Date: 17th January 2020

Reference Number: PBL562

Job Purpose…

The role is to lead, motivate and manage one of the QC Microbiology Units, which provides specialist microbiological testing services in support of licensed pharmaceutical manufacture at PBL, Porton Down, to successfully deliver quality products on time in full in compliance with cGMP. This role will provide line management for a team of circa 8 Quality Professionals.

 We are looking for…

A highly motivated quality professional with drive and passion to inspire and deliver through the team reporting to them. A team player with demonstrated leadership and supervisory abilities. Must be educated to degree level in Microbiology, relevant life-sciences subject, equivalent level qualification or significant experience of working at a similar level in specialist area and ideally have a post graduate qualification in Microbiology. . The post holder will be customer focused and deliver continuous improvement activities and be a subject matter expert for microbiological tests and issues encountered during the manufacturing and testing of PBL licensed products.

The post holder will…

  • 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..
  • Manage, lead and motivate one of the QC Microbiology Units in the planning, resource management, direction and performance of specialist microbiological analyses and testing including bioburden, endotoxin, microbial identification, sterility, environmental monitoring and water testing to regulatory/customer requirements to support pharmaceutical manufacture.
  • 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.
  • Support PBL in performance of validation programmes to meet regulatory/customer requirements.
  • 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.
  • To manage the timely release of QC Microbiology results.
  • Provide specialist training to one of the QC Microbiology Units and also to personnel involved in GMP manufacturing activities at PBL if required.
  • Maintain up to date awareness of regulatory and scientific advances by attending training courses and meetings that contribute to the efficiency and effectiveness of staff training and working practices that are beneficial to the post holder’s development.
  • Suggest and implement changes to work practices/procedures within the framework of regulations.
  • Undertake work in accordance with the Porton Down site Health and Safety policies and procedures and work within any Quality Systems that are applicable to the site.
  • Deputise for the QC Microbiology Manager, when required.
  • Use LIMS to support the management of a compliant and efficiently run laboratory.

The successful applicant should be prepared to participate in out of hours on call rota if required and be prepared to meet the requirements of manufacturing schedules which may include working out of hours or weekends.

For further information regarding this role please contact: recruitment@portonbiopharma.com

Applicants are strongly advised to use the criteria in the job description/person specification as sub-headings in their application to make it clear how they meet each of the selection criteria.

Porton Biopharma Ltd promotes diversity in the workplace and is an equal opportunities employer

To download the job description please click here

PBL563 Executive Assistant

Salary: Circa £23,000 per annum

Closing Date: 24th January 2020

Reference Number: PBL563

Job Summary…

The post holder will be responsible for providing effective and efficient administrative support to the Executive Team (Directors) as well as providing clerical support to the HR team as and when required.

Typical responsibilities (not limited) will include diary management, attending meetings and preparing accurate and timely minutes, the administration of purchase orders & invoices, booking travel & accommodation, collating documentation for the purpose of departmental audits, administration of staff absence on internal systems and recruitment administration.

The post holder will…

  • Be responsible for providing high level administrative support to the Executive Team (Directors).
  • Manage demanding diaries, arrange meetings and take minutes at various operational meetings.
  • Taking a very ‘hands-on’ approach, do everything necessary to organise and ensure the smooth running of events for the business.
  • Organise travel and provide administrative support to departmental audits and being responsible for and maintaining records for expenditure; coordination of monthly reports, etc.
  • Manage multiple tasks and various operational priorities.

We are looking for…

A highly motivated, committed and experienced professional who has strong prioritisation skills and is able to work under pressure. The successful candidate will have excellent attention to detail and advanced IT and office management skills. You will also need a willingness to enhance and learn skills that will allow you to develop and support the growth of the business. Candidates should have significant secretarial or administrative experience at senior level and hold GCSE’s in Maths and English at Grade C or higher or equivalent qualifications. An NVQ Level 3 or equivalent qualification in Business Administration is desirable but not essential.

To apply for this position please submit a CV and cover letter using the criteria in the job description/person specification as sub-headings to identify how you meet each of the selection criteria and outline why you would like a career at Porton Biopharma Ltd.

Porton Biopharma Ltd promotes diversity in the workplace and is an equal opportunities employer

To download the job description please click here

PBL564 HR and Recruitment Coordinator

Salary: Circa £27,000 gross per annum

Closing Date: 28th January 2020

Reference Number: PBL564

Job summary...

The HR and Recruitment Coordinator will support the PBL HR generic administration and recruitment process by coordinating all PBL vacancies, processing recruitment paperwork, supporting recruiting managers, assisting with interview arrangements, liaising with payroll, administering HR-related documentation such as contracts of employment; personnel files; new starter paperwork; pre-employment checks and GDPR compliant documentation, provide basic recruitment advice to staff and managers. They will ensure the continual improvement of HR processes and services and produce HR and recruitment data for key stakeholders.

The post holder will

  • Be responsible for coordinating an effective and efficient end-to-end recruitment service to fulfil hiring needs across the business
  • Coordinate a busy caseload of vacancies supporting hiring managers through the process
  • Process pre- employment paperwork in line with internal processes and GDPR
  • Support hiring managers with the recruitment life cycle and assisting with job adverts, interview arrangements and interviews
  • Provide basic recruitment advice to staff and managers on PBL recruitment policies and procedures and be instrumental in ensuring the continual improvement of PBL HR processes
  • Demonstrate a high level of service at all time
  • Have excellent attention to detail and the ability to spot errors and inconsistencies
  • Have excellent administration skills
  • Familiarity with HR databases, applicant tracking systems and candidate management systems
  • Familiarity with social media, especially LinkedIn
  • Ability to prioritise and complete projects within deadline
  • Hands on experience with various selection processes like phone interviews and reference checks

We are looking for…

An enthusiastic and experienced individual to support the generic HR administration activities and coordinate the end-to-end recruitment process. The successful candidate will have previous recruitment administration experience and a keen interest in this area. The post holder will be highly organised and have strong communication skills, both verbal and written. They will be able to prioritise a demanding workload in line with requirements, whilst maintaining accuracy and delivery. This role has lots of variety and will suit someone who enjoys a fast pace working environment.

For further information regarding this role please contact: recrutiment@portonbiopharma.com quoting "CV- HR & Recruitment Coordinator"

To apply for this position please submit a CV and cover letter using the criteria in the job description/ person specification as sub-headings to identify how you meet each of the selection criteria and outline why you would like a career at Porton Biopharma Ltd.

Porton Biopharma Ltd promotes diversity in the workplace and is an equal opportunities employer.

 

To download the job description please click here