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Scientist/Engineer - Upstream Manufacturing Technology and Sciences

Scientist/Engineer - Upstream Manufacturing Technology and Sciences
Designs and documents experimental studies, preparation, review and approval of study designs, protocols, technical documents and final reports in alignment with priorities for each process.
Ensures laboratory maintenance to sustain a safe, effective and productive environment and ensures that appropriate GLP/GMP procedures are followed where appropriate
Troubleshoots process related problems observed at manufacturing scale through the effective design of scale-down studies and evaluates data from manufacturing lots
Interacts with global Health Authorities for site inspections and CMC authoring and review of regulatory filings (IND, IND amendment, BLA, MAA, PAS, etc.) and inquiry responses
Collaborates with cross functional teams and representatives of other organizations outside of Manufacturing Sciences and Technology on the site and throughout the company
Sustains a high level of innovative thinking and independent research.
Participates in drug substance manufacturing support teams as a team member
Participates or directs team at developing or advancing technology for implementation in lab and manufacturing operations
Organizes and conducts meetings and ability to execute projects as part of a team
Specific Knowledge, Skills, Abilities, etc: (describe the most critical competencies which are required to perform the job)
Knowledge in most areas of laboratory or commercial-scale mammalian cell culture or microbial fermentation, stem cell, including process development, process characterization, process troubleshooting, continuous improvement and media development, bioreactor scale-up and scale-down modeling
Experience in experimental design, data analysis, process modelling, data and document review and scientific presentations.
Demonstrated collaborative experience and ability to effectively work through others
Experience experimental design and using statistical software package or multivariate package
Experience in computational fluid dynamic modeling is a bonus
Strong technical and communication skills, both verbal and written
Ability to self-motivate, multi-task, and meet frequently tight deadlines
Organized and disciplined record keeping in lab notebooks
Desire to work within a highly regulated environment and be involved in regulatory submissions and inspections
Education/Experience/ Licenses/Certifications: (list required education and experience, along with any additional education/experience/qualifications that are preferred)
A B.A./B.S. (10 years), M.S. (5 years) Ph.D. (0 to 3 years) in Biological or Biochemical/Chemical/Biomedical Engineering, Biochemistry, Biotechnology, Bioengineering, or Bioprocessing discipline with experience in stem cell, mammalian cell culture, or microbial fermentation.



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