Manager- MSAT Downstream Lead

Thermo Fisher Scientific • Plainville, MA

6d • Onsite

About The Position

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Thermo Fisher Scientific - Viral Vector Services (VVS) is a rapidly growing, multifaceted gene therapy contract development and manufacturing organization (CDMO) that is seeking experienced individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization for our client partners and the patients we serve. We This position is part of Chemistry, Manufacturing and Controls (CMC) Development team and part of Manufacturing Science and Technology (MSAT). Manager MSAT Downstream will: Serve ad subject matter expert on all downstream and drug product technology transfer activities. Lead technology transfer to GMP from clients or the internal development team, including process/facility gap assessments and drafting/reviewing GMP documents (batch records, tech transfer protocols, sampling plans). Lead the downstream tech transfer team; build and develop a team of downstream and drug product scientists and engineers to drive successful tech transfer. • Collaborate closely with GMP Manufacturing, Quality Control, Quality Assurance, Engineering, and Development to ensure a successful transfer that yields a robust process. • Collaborate closely with upstream tech transfer MST team and the site Process Validation team to ensure PPQ readiness; co-author PPQ protocols and reports, ensuring GMP compliance. • Serve as the subject matter expert across gene therapy process and analytical methods. • Drive quality management by triaging deviations, leading RCA/CAPAs, and implementing change controls related to process, materials, and equipment. • Drive process, quality, and operations risk assessments and change controls for new product introductions.

Requirements

• B.S. in Chemistry, Biochemistry, Engineering or related field with 8 yrs., Masters with 6 yrs, or Ph.D. with 3 yrs. Of industrial experience!
• 5+ years of hands-on experience in Manufacturing Sciences for AAV, lentivirus, and gene therapy preferred; minimum 3 years required.
• Deep technical expertise in gene therapy scale-up and downstream processing is required.
• Excellent resource management and prioritization skills required.
• Outstanding ability to analyze, interpret, and synthesize data; define problems; establish facts; draw valid conclusions; and make decisions.
• Detailed understanding of regulatory guidelines (FDA, EMA, and other relevant authorities).
• Excellent troubleshooting skills with the ability to resolve sophisticated technical issues.
• Strong interpersonal and communication skills, both verbal and written
• Ability to apply Good Manufacturing Practice (GMP) principles and knowledge of pharmaceutical processes, equipment, instrumentation, and procedures.
• Presence on the manufacturing floor with strict adherence to GMP cleanroom guidelines.

Nice To Haves

• 3+ years of leadership experience managing scientific/technology teams is helpful.
• Preferred experience building, implementing, and leading a Manufacturing Sciences function with exposure to both USP and DSP strategies.

Responsibilities

• Serve ad subject matter expert on all downstream and drug product technology transfer activities.
• Lead technology transfer to GMP from clients or the internal development team, including process/facility gap assessments and drafting/reviewing GMP documents (batch records, tech transfer protocols, sampling plans).
• Lead the downstream tech transfer team; build and develop a team of downstream and drug product scientists and engineers to drive successful tech transfer.
• Collaborate closely with GMP Manufacturing, Quality Control, Quality Assurance, Engineering, and Development to ensure a successful transfer that yields a robust process.
• Collaborate closely with upstream tech transfer MST team and the site Process Validation team to ensure PPQ readiness; co-author PPQ protocols and reports, ensuring GMP compliance.
• Serve as the subject matter expert across gene therapy process and analytical methods.
• Drive quality management by triaging deviations, leading RCA/CAPAs, and implementing change controls related to process, materials, and equipment.
• Drive process, quality, and operations risk assessments and change controls for new product introductions.

Benefits

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees