Manager, Upstream Process Development
Thermo Fisher Scientific

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Whether our customers are accelerating life sciences research, solving complex analytical challenges, or improving patient diagnostics and therapies, we are here to support them.

When you join our team, you'll do important work. Things like helping customers in finding cures for cancer, protecting the environment, or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals. You'll also have the opportunity for continual growth and learning in an environment that will support your development.

We are seeking an upbeat and hard working dividual with strong communication, leadership, technical and operational skills to join our growing Process Development team.

Job Title: Manager - Upstream Process Development - Gene Therapy

Location/Division Specific Information: US - Massachusetts - Plainville

How will you make an impact?

Our group leads all aspects of process development, characterization, scale up of gene therapy molecules from pre clinical to clinical and commercial phase. As the Upstream development lead, you will help our clients to deliver lifesaving and life changing therapies to patients. You will be planning, leading the operation, and detailing laboratory and tech transfer activities in support of process establishment, pilot, and transfer into cGMP manufacturing. You will also act as domain expert in supporting transfer and operation of internally developed and client transferred processes. You will also be supporting tech transfer out to the cGMP manufacturing space.

What will you do:

• Lead multiple projects; run project timelines. Own the design and execution of experimental plans.
• Serve as a SME for development for upstream viral vector therapeutic processes. Training junior team members.
• Collaborate with clients, ensures accurate data and presentations to presented clients.
• Collaborate with global Process Development and Manufacturing, Quality, and Project Management teams to facilitate technology transfer and project success.
• Draft, review, and approve technical plans, reports, and protocols.
• Assess technical gaps/facility fit challenges for new clients/processes.
• Lead Practical Process Improvement (PPI) initiatives.

How will you get here:

Education

• B.S. in Chemical Engineering, Biochemistry, Biology or related field with 8 yrs, Masters with 5 yrs, or Ph.D. with 3 yrs. Including leadership experience.

Experience:

• Execution of small-scale shake flask, 2-D multilayer flask and stirred tank bioreactor studies to support the development of cell, virus, and plasmid DNA-based gene therapy upstream manufacturing processes.
• Working with fed-batch and perfusion cell culture in transfection- and infection-based viral vector gene therapy process development is desired.
• Scale-up of upstream processes, supports process characterization and validation activities.
• Collaborating with Downstream and Analytical Testing/Development teams to build process understanding and design space.

Knowledge, Skills, Abilities:

• Expert level knowledge of mammalian and insect cell-culture, virology, transient transfection, and infection processes.
• Hands on experience with high-throughout upstream technologies such as AMBR system
• Deep understanding of statistical analyses: DOE design, parameter criticality assessment, etc.
• Understanding of cell metabolism, metabolic flux, PAT would be particularly desirable along with knowledge and experience in using system biology approach to gain deep biology understanding.
• Experience in scale up-down of bioreactor processes.
• 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) is desired.
• A flexible work schedule might be required (Weekends and nights as needed to support lab activities).

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate since race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

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