Associate Scientist - Cell and Gene Therapy

    • Stevenage, United Kingdom

Site Name: UK - Hertfordshire - Stevenage
Posted Date: Jul 30 2020
GSK is seeking Associate/Sr Associate Manufacturing Scientists to commission a cell and gene therapy manufacturing facility and subsequently lead the manufacture of clinical drug product material. The Manufacturing Associates will assist in the design and commissioning of the manufacturing facility, the validation of equipment and processes, the development of processes and procedures for manufacturing operations and support activities (technology transfer, validation, release...etc), the technology transfer of early to late phase processes, and ultimately the manufacture of Cell and Gene Therapy (CGT) clinical Drug Product.

This is an exciting opportunity to support a growing clinical portfolio of CGT medicines within a world leading science-based pharmaceutical company. As a member of the Manufacturing team, the individual will directly participate in manufacturing operations and help deliver clinical drug product to patients by contributing to the Right First Time culture and promoting and adhering to the relevant safety, quality, and compliance standards and requirements.
The ideal candidate must have experience in GMP manufacturing of cell and gene therapy, biopharmaceuticals or vaccines, a good understanding of regulations, and the ability to lead, influence, and motivate functional line and cross-functional teams.

Primary Responsibilities:

  • Establish a GMP manufacturing facility through to clinical manufacturing readiness: design, construction, commissioning and validation of facility and equipment, development of systems, processes, and procedures
  • Draft Standard Operating Procedures (SOPs) and Master Batch Records (MBRs) for various activities including manufacturing operations, validation, calibration, technology transfer, and cleaning and maintenance
  • Assist in the development and execution of technology transfers to enable robust clinical supply initially with the potential for commercial supply at a later date
  • Perform daily operations of a multi-product GMP facility based on procedures and ways of working. Hands-on cGMP drug product manufacture including buffer/media preparation, equipment setup and calibration, cell washing, selection, transduction, culture, harvest, formulation and filling.
  • Ensure all manufacturing and validation activities are completed in accordance with quality and regulatory expectations to support relevant global regulatory submissions
  • Strives for Right First Time in the manufacture of clinical material through attention, focus, planning, and adherence to procedural and regulatory expectations
  • Review and approve executed processing documentation such as Batch Records (BRs) prior to submission to Quality Assurance (QA) to insure adherence to cGMPs and proper documentation practices
  • Collaborate with QA to ensure GMP compliance, draft deviation investigations and manage CAPA implementation. Maintain the facility, systems, and processes in continuous inspection readiness state
  • Provide subject matter expertise for cell process manufacturing operations. Provide technical leadership in solving process issues involving equipment, scale, raw materials, process optimization, and process changes
  • Collate and trend process monitoring data in scope of a control strategy. Implement electronic Batch Records (eBRs), once volume triggers are met
  • Contribute to the implementation of process and operational improvements to target reduction in Cost of Goods (CoGs) and Release Cycle Time
  • Support regulatory filings and response to questions. Author and review CMC sections for global regulatory submissions (IND/BLA, IMPD/MAA, and others)
  • Provides training and guidance to less experienced personnel
  • Assist in the development and industrialization of technology essential to cGMP production. Keep aware of new technology developments
  • Perform cleaning of manufacturing equipment and area
  • Contribute to building a culture of empowerment and accountability. Main KPIs will be Right First Time, Release Cycle Time, Adherence with Quality Metrics, and Safety Culture

Required Qualifications:
  • Bachelor in Chemical Engineering, Biochemistry, Biology, Chemistry or a related discipline or equivalent experience.
  • Good oral and written communication skills and strong scientific, management, and organizational skills
  • Ability to work in a fast-paced and dynamic environment with competing priorities and deliver departmental goals
  • Level Differentiators:
    • Relevant industrial experience in cell and gene therapy, biopharmaceuticals, or vaccines manufacturing. Technical knowledge and hands-on experience in GMP manufacturing. Experience with autologous cell and gene therapy manufacturing
    • Knowledge and experience of cell and gene therapy GMP and CMC regulations, including ATMP regulations. Experience in CMC regulatory affairs for US FDA and EMA
    • Experience with GMP facility design and commissioning, equipment selection, qualification, and validation
    • Knowledge of regulatory guidelines, validation practices, and other relevant regulatory requirements
    • Experience with technical transfer of clinical and commercial stage products

As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class(US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Please don't hesitate to contact us if you'd like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on 0808 234 4391, or send an email

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