Thermo Fisher Scientific · 3 days ago
QC Manager, Bioanalytical
Plainville, MA
Full-time
Onsite
Mid, Senior Level
$103K/yr - $155K/yr
6+ years expThermo Fisher Scientific is a company focused on enabling customers to make the world healthier, cleaner, and safer. The Manager, Quality Control Bioanalytical & Analytical Transfer leads the bioanalytical QC and transfer activities, ensuring compliance with cGMP standards and overseeing lab staff. Responsibilities include coordinating QC activities, hiring and training staff, and serving as the primary technical liaison with clients.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
Responsibilities
Lead all aspects of and drive the Bioanalytical lab operational readiness plan to ensure on-time approval of analytical equipment and test methods needed for GMP testing
Build a trained, competent team of QC analysts to support GMP testing
Coordinate daily Quality Control activities for Molecular, Viral, Cell, and Tissue Culture operations and contract testing. Ensure compliance, accuracy, and timeliness of testing processes. Lead the introduction of new technology, equipment, methodologies, and validations. Provide QC leadership and support across the VVS organization. Facilitate cross-functional communication and ensure all testing processes, metrics, and departmental goals are achieved
Strive to implement and improve systems and drive efficiency throughout the organization
Support internal, external, and regulatory inspections as needed
Hire and develop employees within the department. Assign work, coach staff, and take vital disciplinary actions
Serve as primary QC Bioanalytical contact for regulatory inspections and client audits
Provide support for method qualification and validation from Assay Development and Analytics and/or clients
Support the establishment and/or enhancement of QC and operational metrics
Provide frequent overall departmental feedback to senior management
Ensure adequate staffing is hired and trained
Qualification
Required
BS required, MS preferred in a scientific/technical field
6-8 years of experience in a quality position within the biological and/or pharmaceutical industry required
Experience with writing Deviations, Lab investigations, and OOS required; experience with Root Cause Analysis required
2-3 years experience leading teams in a fast-paced environment required
Experience with regulatory inspections from the FDA, EMA, Health Canada, or other regulatory authorities required
Capable of writing reports, business correspondence, and procedure manuals
Strong organizational skills; ability to prioritize and lead through complex processes/projects
Ability to read, analyze, and interpret business periodicals, common scientific, professional, and technical journals, financial reports, governmental regulations, and legal documents
Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community
Ability to effectively present information to employees, top management, public groups, and/or boards of directors
Ability to interpret and carry out an extensive variety of technical instructions in written, oral, schedule, mathematical, or diagram form
Ability to define problems, collect data, establish facts, and draw valid conclusions
Ability to apply principles of logic or scientific thinking to a wide range of intellectual and practical problems
Able to lead abstract and concrete variables in situations where only limited standardization exists
Preferred
MS preferred in a scientific/technical field
Significant experience in supporting functional areas (e.g., PD, Manufacturing, QA, Engineering, EHS) preferred
PhD in a scientific/technical field is a plus
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
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (272)
2024 (224)
2023 (233)
2022 (342)
2021 (315)
2020 (227)
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
Stephen Williamson
Senior Vice President and Chief Financial Officer
Daniella Cramp
Senior Vice President and President, Bioproduction Group
Recent News
2026-01-09
Research & Development World
2026-01-09
EIN Presswire
2026-01-07
Company data provided by crunchbase