Senior Scientist (Upstream Tech Transfer)

Senior Scientist (Upstream Tech Transfer)

Introduction to role:

Join us in the Cell Culture and Fermentation Sciences (CCFS) department within Biopharmaceutical Development (BPD). As a Senior Scientist, you will lead process transfer by working directly with process development scientists (located in the US and UK), clinical/commercial manufacturing organizations, CMOs, and QA to ensure appropriate scale-up and transfer of clinical and commercial upstream processes to GMP manufacturing production. Be comfortable with uncertainty and ambiguity, work with lots of unknowns where change is the only constant. We thrive in this environment of pace and ambiguity, taking calculated risks and getting it done. It takes resilience, and for us it makes it even more rewarding when we get a new medicine to our patients.

Main Duties & Responsibilities:

• Transfer multiple projects as upstream cell culture tech transfer project lead/ representative. Serve as upstream process subject matter expert (SME) to perform fit-to-plant, process risk analysis, timely generation of cell culture process tech transfer documentation, batch record review/approval, technical collaboration with receiving organizations, campaign monitoring and support, performance analysis and interpretation, investigation support, campaign summary report authoring, and routine presentations to cross-functional teams and the management

• Build and maintain effective working relationships with internal stakeholder groups and potentially external CMOs to successfully advance AZ’s Biologics portfolio.  Proactively addresses risks/issues to avoid non-conformances and enable efficient transfers

• Serve as SME and provide technical support to manufacturing within AZ and external partners

• Support building the tech transfer roadmaps for accelerated development timelines, and novel biologic modalities.  

• Effectively communicate and collaborate in a matrix team setting to implement technical solutions

• Author, review, and approve technical documents, CMC sections of regulatory submissions (INDs/BLAs), and responses to questions from health authorities.

• Contribute to the improvement of the tech transfer business processes through idea generation and implementation activities

• Position requires periodic weekend work and/or occasionally late-night calls (manufacturing support or international collaborations).  Position might require some travel to CMOs or other AZ sites (domestic and international).

Education & Experience Requirements:

Education: BS, MS, or PhD in an engineering or scientific field such as biological sciences. A focus in a process engineering field (e.g., chemical, or biochemical engineering) is preferred but not required.

Experience: BS degree and 7+, MS and 5+, or a PhD and 0+ years of relevant industry or research-related experience is required

Essential Skills/Experience:

• Knowledge and experience of cell culture process development including fed-batch or perfusion processes, platform development, process scale-up, and manufacture.

• Demonstrated experience in transferring cell culture processes to the GLP or GMP manufacturing facilities.

• Hands-on experience with bioreactors (bench, pilot, or production scales).

• Fundamental understanding of upstream cell culture unit operations and scale-up/scale-down principles for the manufacture of biopharmaceutical products.

• Experience and knowledge of GMP manufacturing principles and documentation.

• Ability to identify and solve complex bioprocess and manufacturing technical problems in a timely manner.

• Ability to defend or propose a technical decision.

• Experience with data and statistical analysis.

Desirable Skills/Experience:

• Experience with cell culture harvest operation including primary clarification via continuous centrifuge, or direct depth filtration.

• Experience working in a cGMP-regulated environment and/or large-scale bioprocessing laboratory/facilities.

• Skilled in conducting process transfer/process development/technology development projects.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.<