Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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).

Job Title: Sr Manager – MSAT Technology Transfer Lead

Location: US - Massachusetts – Plainville | 100% onsite

Division Specific Information: Pharma Services | Viral Vectors

How will you make an impact?

Sr Manager role will:

• 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 tech transfer team; build and develop a team of 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 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 leading deviations, leading RCA/CAPAs, and performing change controls related to process, materials, and equipment.

• Drive process, quality, and operations risk assessments and change controls for new product introductions.

Education & Experience

B.S. in Chemistry, Biochemistry, Engineering or related field with 12 yrs., Masters with 8 yrs., or Ph.D. with 5 yrs. of industrial experience including leadership experience.

Knowledge, Skills, Abilities10+ years of hands-on experience in Manufacturing Sciences for AAV, lentivirus, and gene therapy preferred; minimum 5 years required.5+ years of leadership experience managing scientific/technology teams required.Preferred experience building, implementing, and managing a Manufacturing Sciences function with exposure to both USP and DSP strategies.End-to-end technical understanding of gene therapy manufacturing processes is required; demonstrated in-depth expertise in downstream processing (DSP) is a plus.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.Thorough understanding of regulatory guidelines (FDA, EMA, and other relevant authorities).Excellent troubleshooting skills with the ability to resolve complex technical issues.Strong interpersonal and communication skills, both verbal and written.Work Environment/Physical RequirementsThis position requires working regular business hours and, when needed, outside business hours (including evenings, weekends, and holidays).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.