Sr Manager, Downstream Process Development

Job Description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 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: Sr Manager - Downstream Process Development

Location/Division Specific Information: US - Massachusetts – Plainville - Onsite

How will you make an impact?

In Viral Vector Service BioProcess Sciences, we develop, characterize and scale-up bioprocesses for robust manufacture of viral vectors to help our clients deliver lifesaving therapies to patients.

As manager of downstream process development, you will lead a team of scientists responsible for planning, design, implementation, and documentation of laboratory and tech transfer activities. You will also serve as domain expert in downstream processing for viral vector while supporting detailed transfer of processes from clients into Bioprocess Sciences lab. You will also be supporting tech transfer out to the cGMP manufacturing space.

What will you do?      

• 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.

How will you get here?

Education

• 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.

Required Knowledge, Skills, Abilities

• 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).

Desired Knowledge, Skills, and Abilities

• 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)

While performing the duties of this job, the employee:

• Will work in a dynamic environment and balance multiple priorities simultaneously!
• Will be self-motivated and proactively drive efficient execution.
• Will be encouraged to learn new software, processes, and tools quickly!
• Will use outstanding equipment and instrumentation in daily manufacturing.
• Will demonstrate flexibility with changes to working environment and deliver high quality results.
• Will critically review processes and recommend improvements to supervisor/manager

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.

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.