Thermo Fisher Scientific · 12 hours ago
Sr. Scientist – Quality Compliance / Change Control
Boston, MA
Full-time
Onsite
Mid, Senior Level
$95K/yr - $110K/yr
4+ years expThermo Fisher Scientific is a leading global contract research organization focused on enabling customers to make the world healthier, cleaner, and safer. They are seeking a Sr. Scientist for Quality Compliance / Change Control, who will be responsible for managing change controls, supporting internal audit programs, and ensuring compliance within analytical development.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
No H1B
Responsibilities
Be the Analytical Development (AD) point of contact for change controls. Responsibilities include but not limited to: participate in change control review, evaluate impact to AD and collaborate with SMEs for joint assessment, initiate, track and close change control record
Support internal audit programs to ensure compliance and pre-approval inspection readiness
Assist in the revision of governance SOPs for AD, including but not limited to Method Validation and Method Transfer, Establishing Specification
Review analytical data. Perform data verification to ensure accuracy and completeness of information presented in analytical documents and regulatory filings (IND/BLA)
Propose and implement ways to ensure and improve timely closure of change control, investigation, CAPA, ELN and completion of trainings
Support other analytical development activities as needed
Qualification
Required
Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years')
OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years')
OR PhD
Relevant Analytical Development, Quality Control or Quality Assurance experience is required
Attention to detail and follow up with collaborators to ensure timely completion of assignment
Ability to communicate to a wide variety of audiences, exchanges complex and sensitive information and gain alignment around a proposed action
Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and efficiency
Excellent technical writing skills are essential
Knowledge of relevant ICH and regulatory guidelines and good understanding of GMP concept
Hands-on experience and In-depth knowledge of change control, deviations, CAPA and investigation
Must be legally authorized to work in the United States without sponsorship
Must be able to pass a comprehensive background check, which includes a drug screening
Preferred
Experience in biologics, gene and cell therapy is desirable
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
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$15.97BKey Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B
Leadership Team
Marc Casper
CEO
Stephen Williamson
Senior Vice President and Chief Financial Officer
Recent News
CB Insights
2026-01-23
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