Reference
PRSCCEPR
Type
Permanent
Location
Oxford
Salary
Up to £60k per annum
Category
Research & Development
Sector
Pharmaceuticals / Biotechnology / FMCG

ABOUT THIS ROLE

Our client is expanding its CMC expertise within the organisation, to deliver a pipeline of Cell and Gene Therapy products, including autologous ex vivo gene modified TCR-T therapeutics, to patients with cancer. We are now looking for a dynamic person with extensive scientific, cell process and/or analytical development experience to build the bridge between research and GMP manufacturing. The role is multifaceted in working closely with the internal research teams on cross-functional projects, such as the development of next gen products, leading cell process and/or analytical development, and the assessment of novel methods and technologies. Further, the role will act as SME on projects with our external partners to establish robust cell processes and analytical methods.

KEY RESPONSIBILITIES

Partner with the research team to establish robust GMP compliant cell culture processes and analytics to rapidly advance next gen and new clinical candidates from the pipeline into manufacturing

· Transfer knowhow on cell manufacturing and analytical methods to and from external partners under development / GMP tech transfer

· Liaise and act as SME with external manufacturing, testing, supply, and development partners

· Troubleshoot external manufacturing and supply activities

· Clearly communicate problems, risks and potential impact on timelines, as well as recommended solutions to senior management

· Develop and execute on project plans to assess novel cell process and analytical technologies and methods internally and with external partners

· Author, review, and keep record of protocols, manufacturing and analytical documentation and reports

· Provide scientific and technical expertise to and/or lead research and development project teams

· Support in development / write documents for regulatory submission packages for IND/ IMPD submissions

THE IDEAL CANDIDATE

Degree in Life Sciences or related discipline

· Substantial and relevant post-graduate experience within academic or industry setting, preferably including an MSc or PhD

· Proven experience of working to objectives and timelines

· In-depth T-cell biology, process and analytical understanding

· Understanding of GMP regulations

· Extensive laboratory experience with cell culture and process development, ideally with primary human T cells at various scales

· Strong laboratory experience with assay development and analytical methods such as cell counting, phenotypic and functional cell characterisation (flow cytometry, cytokine detection, etc.)

· Excellent communicator, both written and verbal

· Self-motivated and enthusiastic team player with strong attention to detail

· Computer literate and ability to familiarise with different IT systems

Desirable:

· Experience with external contract R&D, cell manufacturing, and suppliers

· Hands on experience in global Regulatory filings / submission packages

· GMP process / analytical development and validation

· Experience with closed and automated process technology

· DoE

· Experience working in project teams

· Project and/or people leadership experience

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