MSAT Scientist III, Drug Product
Thermo Fisher Scientific
Plainville, Massachusetts, USAPosted Discovered via the company's careers siteMatch locked
Full time5+ years exp
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Title: MSAT Scientist III, Drug Product
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 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.
Location/Division Specific Information
Thermo Fisher Scientific - Viral Vector Services (VVS) is a multifaceted gene therapy contract development and manufacturing organization (CDMO) that seeks sharp 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.
Discover Impactful Work
The Drug Product Scientist, Manufacturing Science and Technology (MSAT), provides advanced scientific and technical leadership for commercial and clinical drug-product manufacturing processes. This role serves as a subject-matter expert for formulation, compounding, filtration, filling, visual inspection, and associated manufacturing operations.
A Day in The Life
- The Scientist III is responsible for technology transfer, process validation, continued process verification, manufacturing investigations, and lifecycle management.
- The role works cross-functionally with Manufacturing, Process Development, Quality, Engineering, Regulatory Affairs, Supply Chain, and external manufacturing partners to ensure processes are scientifically sound, compliant, robust, and capable of consistently delivering products that meets established quality requirements.
Responsibilities
•
Drug-Product Process Support
Provide scientific and technical support for drug-product manufacturing operations
•
Technology Transfer and Process Introduction
Lead or support technology transfers of drug-product processes for clinical and commercial programs.
•
Process Validation
Develop process-validation strategies and author or review process-performance qualification protocols, reports, and support documentation.
•
Investigations and Technical Problem-Solving
Lead or support complex deviation investigations, nonconformance investigations, product-impact assessments, and root-cause analyses.
•
Process Monitoring and Lifecycle Management
Develop and maintain process-monitoring and continued process verification programs.
Education
- Master's degree highly preferred.
- Bachelor's degree in a Pharmaceutical Sciences, Chemical Engineering, Biochemistry, Biotechnology, Chemistry, Biomedical Engineering, or a related scientific or engineering discipline related discipline required.
Experience
- Bachelor's degree in a related discipline with 5-7 years of relevant industry experience required.
- Experience authoring or reviewing GMP documentation, including protocols, reports, deviations, change controls, risk assessments, and technical assessments.
- Demonstrated experience with one or more of the following:
- • Formulation and compounding
- Sterile filtration
- Aseptic filling
- Visual inspection
- Container-closure systems
- Single-use manufacturing systems
- Process characterization and validation
Knowledge, Skills, Abilities
- Significant experience supporting drug-product process development, manufacturing, technology transfer, validation, or commercial lifecycle management.
- Strong understanding of pharmaceutical manufacturing principles and current Good Manufacturing Practices.
- Strong data-analysis and technical-writing capabilities.
- Ability to manage multiple priorities and operate effectively in a fast-paced, matrixed manufacturing environment.
- Strong data-analysis and technical-writing capabilities.
- Ability to manage multiple priorities and operate effectively in a fast-paced, matrixed manufacturing environment.
Work Environment/Physical Requirements (adjust as required)
- Standard office environment with some interaction in GMP manufacturing and laboratory settings.
- May require occasional standing, walking, and use of PPE during client visits or facility tours.
- This role is based 100% onsite at the Plainville, MA facility.
Benefits
We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
Compensation and Benefits
The salary range estimated for this position based in Massachusetts is $83,300.00-$125,000.00. 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: https://jobs.thermofisher.com/global/en/total-rewards
Not included in the source posting: about the role.
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