Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 billion. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. 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 the team at Thermo Fisher Scientific, 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 energetic and enthusiastic individual with strong communication, leadership, technical and operational skills to join our growing Process Development team.

Job Title: Manager - Upstream Process Development

Location/Division Specific Information: US - Massachusetts – Plainville (on-site)

How will you make an impact?

As the Upstream Process Development Lead, you will help our clients to deliver lifesaving and life changing therapies to patients in need. In the process development group, we are responsible for process characterization, scale up and late-stage process development. You will be responsible for planning, executing, and documenting laboratory and tech transfer activities in support of process establishment, pilot, and transfer into cGMP manufacturing. You will also act as a subject matter expert (SME) and support flawless transfer and operation of internally developed and client transferred processes into the process development and pilot space. You will also be supporting tech transfer out to the cGMP manufacturing space. The Upstream Process Development Lead position will be responsible for the design of experimental studies and lead all aspects of the execution with members of the larger team.

What will you do?            

• Lead multiple projects; manage project timelines and deliverables.
• Lead the design and execution of experimental plans and studies based on defined deliverables.
• Lead all aspects of upstream execution with members of the larger team.
• Act as a SME for technology transfer and late-phase development for upstream viral vector therapeutic processes. Training junior team members.
• Interact 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

• Design and 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 via design and execution of in-process testing and control assays.

Knowledge, Skills, Abilities

• Expert level knowledge of mammalian and insect cell culture, virology, transient transfection, and infection processes.
• Understanding of cell metabolism, metabolic flux, PAT, or omics technologies would be particularly desirable along with knowledge and experience in using system biology approach to gain deep biology understanding.
• Experience in scale up and scale 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.
• Ability to function in a rapidly changing environment & handle multiple priorities.
• A flexible work schedule might be required (Weekends and nights as needed to support lab activities).

At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner, and safer.

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

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