Upstream Bioprocessing Expert
ProClinical is advertising a vacancy for an Upstream Bioprocessing Expert position with an internationally leading pharmaceutical company. The organisation, which works across multiple therapy areas, is seeking for a driven and talented applicant to join their team in Cambridge. This is an exciting opportunity to work with a global company that is committed to science and integrity.
The Upstream Bioprocessing Expert will provide technical insight and leadership in the company's biological molecules portfolio, which covers proteins, fusion proteins, and monoclonal antibodies.
- Supporting purification process development, process fit analysis, technical transfer, scale-up, and process validation at company sites.
- Supporting cell line/expression system evaluation and selection activities at CRO sites.
- Supporting cell culture/fermentation process development, process fit analysis, technical transfer, scale-up, and process validation at our CDMO sites.
- Monitoring, evaluating, and maintaining performance of upstream manufacturing at CMOs.
- Maintaining a strong working relationship with internal and external partners in the areas of trouble-shooting, technology review, and new product manufacturing implementation.
- Maintaining technical familiarity with process and process equipment, process optimization evolution, and technical problem solving.
- Reviewing technical documents, protocols, reports, summaries, batch records, and SOPs.
- Preparing and reviewing regulatory documents in sections related to cell culture, fermentation, and other upstream processes.
- Identifying, mitigating and, if necessary, escalating project risks (quality, timeline, budget, and scope) in upstream process development and manufacturing.
- Delivering new science and ways of working to improve project deliveries, driving innovation, and engaging internal and external expertise.
- Forming a network with experts in other departments in AZ and developing a strong scientific community.
- Driving new science and innovation and securing new ways of working to improve project deliveries.
- Engaging internal and external expertise as well as publishing in scientific journals.
- Contributing to the wider scientific and business strategy for the department.
Skills and Requirements:
- An MSc/PhD or equivalent in biochemical engineering, biochemistry, biology or related discipline.
- At least 5 years of experience in the development and manufacture of biological molecules.
- Relevant biologics CMC experience in an industrial setting, including extensive experience working with external CROs and CMOs, with a track record of successfully delivered projects.
- Knowledge of current GMP guidelines and familiarity with regulatory authority submissions (IMPD/IND/BLA).
- Line of sight & preferably knowledge of the overall drug development process from Discovery through to Launch.
- Demonstrated organizational skills and the ability to successfully manage multiple technical projects and priorities.
- Detailed understanding of Biologics Upstream Bioprocessing, including cell line selection, process optimization, scale-up and validation.
- Proficient with any in-process analysis needed to evaluate cell culture and fermentation performance.
- Experience assembling RFPs in collaboration with other functional leads; CMO identification; developing technical/quality agreements in collaboration with QA.
- Experience of Technical Transfer of projects.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency in MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Chidozie Orji at +44 207 440 0671 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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