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MSAT Technology Transfer Lead
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Job Title Sr Manager – MSAT Technology Transfer Lead
Location US – Massachusetts – Plainville (100% onsite)
Division Pharma Services – Viral Vectors
Work Schedule Mon – Fri (Standard)
Environmental Conditions Office
Company Overview Thermo Fisher Scientific – Viral Vector Services (VVS) is a rapidly growing, multifaceted gene therapy contract development and manufacturing organization (CDMO) that seeks experienced professionals to bring the highest quality processes, products and testing to our clients.
Responsibilities
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 years of industry experience; M.S. with 8 years of industry experience; or Ph.D. with 5 years of industry experience including leadership experience.
Qualifications
10+ years of hands‑on experience in Manufacturing Sciences for AAV, lentivirus, and gene therapy; minimum 5 years required.
5+ years of leadership experience managing scientific/technology teams.
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.
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 Requirements
This 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.
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MSAT Technology Transfer Lead
role at
Jobs via Dice
Job Title Sr Manager – MSAT Technology Transfer Lead
Location US – Massachusetts – Plainville (100% onsite)
Division Pharma Services – Viral Vectors
Work Schedule Mon – Fri (Standard)
Environmental Conditions Office
Company Overview Thermo Fisher Scientific – Viral Vector Services (VVS) is a rapidly growing, multifaceted gene therapy contract development and manufacturing organization (CDMO) that seeks experienced professionals to bring the highest quality processes, products and testing to our clients.
Responsibilities
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 years of industry experience; M.S. with 8 years of industry experience; or Ph.D. with 5 years of industry experience including leadership experience.
Qualifications
10+ years of hands‑on experience in Manufacturing Sciences for AAV, lentivirus, and gene therapy; minimum 5 years required.
5+ years of leadership experience managing scientific/technology teams.
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.
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 Requirements
This 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.
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