Manager- MSAT Downstream Lead

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds 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: Manager MSAT Downstream Lead

Location: US - Massachusetts Plainville 100% onsite

Division Specific Information: Pharma Services Viral Vectors

How will you make an impact

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.

Education & Experience

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!

Knowledge Skills Abilities

• 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.
• 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.
• 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

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.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:

• 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

For more information on our benefits please visit: Experience:

Manager