50 Senior Scientist (Upstream Tech Transfer) Jobs in Gaithersburg, MD
AstraZeneca is Hiring a Senior Scientist (Upstream Tech Transfer) Near Gaithersburg, MD
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).
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.
- 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.
At AstraZeneca, you will play an essential role in helping patients who need it the most. There is no better place to apply your Biometrics expertise in a new and different way. With a restless need to keep improving, we are always moving forward and searching for something new. Our supportive, yet challenging, approach makes for an inspiring learning environment. Every setback is seen as a chance to improve, every critique pushes us towards the next ground-breaking solution.
Are you ready to make a profound impact with research that makes a clear and tangible difference? Apply now and join us in our mission to create life-changing medicines!
Job Summary
Full Time
Pharmaceutical
$150k-184k (estimate)
06/29/2024
07/26/2024
astrazeneca-us.com
SOUTH SAN FRANCISCO, CA
7,500 - 15,000
Product/Brand/Service
TRUONG DANG
$1B - $3B
Pharmaceutical
Related Companies
The job skills required for Senior Scientist (Upstream Tech Transfer) include Presentation, Collaboration, Cell Culture, Process Development, Communicates Effectively, etc. Having related job skills and expertise will give you an advantage when applying to be a Senior Scientist (Upstream Tech Transfer). That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Senior Scientist (Upstream Tech Transfer). Select any job title you are interested in and start to search job requirements.
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