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Thermo Fisher Scientific · 2 days ago
Sr Manager, Downstream Process Development
Plainville, MA
Full-time
Hybrid
Director
5+ years exp
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BioinformaticsBiotechnology
Insider Connection @Thermo Fisher Scientific
Responsibilities
Lead and manage a team of scientists dedicated to downstream process development, fostering a high-performance culture and establishing a comprehensive training matrix for skill development. Provide mentorship to junior scientists to enhance their professional growth.
Oversee the planning and execution of tech transfers, process development, and scale-up activities, encompassing both bench and pilot scale. Ensure seamless coordination between teams for successful project outcomes.
Author and review critical documents, including development plans, batch records, SOPs, protocols, and summary reports. Contribute to the preparation of detailed process development reports, catering to products at various phases.
Take the lead in independently designing Design of Experiments (DOEs), supervising study execution, and conducting thorough analysis of study results for client reporting.
Collaborate closely with the Engineering and Automation team to manage the sourcing, purchase, installation, startup, calibration, and maintenance of downstream process development equipment.
Foster collaboration with the global BPS team, Quality, and Project Management teams to streamline technology transfer processes and ensure project success.
Champion Practical Process Improvement (PPI) initiatives, contributing to continuous enhancement of operational efficiency.
Qualification
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Required
B.S. in (bio)Chemical Engineering, Biochemistry, or related field with 12 yrs, Masters with 8 yrs, or Ph.D. with 5 yrs of industrial experience including leadership experience
Strong practical knowledge of downstream purification process development for common gene therapy vectors (Adeno Associated Virus, Lentivirus, and adenovirus)
Expertise in design and execution of chromatography, tangential flow filtration, depth filtration, viral clearance, and ultracentrifugation studies to support scale up, development, and characterization of gene therapy processes
3+ years experience leading a process development team
Prior viral vector purification development experience
Experience in scale up and scale down of purification processes
Ability to function in a fluid environment & balance priorities
A flexible work schedule might be required (Weekends and nights as needed to support lab activities)
You may be required to support other VVS MA sites as needed
Preferred
Knowledge of drug product formulation and fill finish
Understanding of cGMP and regulatory requirements of biopharmaceutical manufacturing
Strong interpersonal and communications skills; written and oral
Experience with technology transfer, facility fit assessment, statistical analysis methodology and software (JMP or similar tools)
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
10,001+ employees
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (173)
2022 (314)
2021 (349)
2020 (251)
Funding
Current Stage
Public CompanyTotal Funding
$11.05BKey Investors
National Grid
2023-08-07Post Ipo Debt· $2.95B
2023-03-27Grant· $0.5M
2022-11-15Post Ipo Debt· $1.29B
Leadership Team
Daniella Cramp
Senior Vice President and President
Frederick Lowery
Senior Vice President Thermo Fisher and President Customer Channels
Recent News
2024-05-26
Company data provided by crunchbase
