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Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office

Job Description

Tile: QC, Manager, Bioanalytical

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 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

Reporting to the Plainville, MA site and supporting the **Viral Vector Services (VVS)** , a division of Thermo Fisher Scientific. At VVS, we deliver from process development through commercial supply, offering the expertise and resources vital to help clients deliver innovative gene therapies. We are placed at the forefront of our leading and groundbreaking Cell and Gene Therapy business, enabling clients to cure genetic, rare, and otherwise untreatable diseases.

Discover Impactful Work:

The Manager, Quality Control Bioanalytical & Analytical Transfer provides leadership and technical expertise for bioanalytical QC and analytical method transfer activities. Responsibilities include qualification, validation, and transfer of molecular and bioanalytical assays (including qPCR and ddPCR) into the cGMP QC laboratory.

A Day in the Life:

+ Lead a Quality Control team responsible for ensuring product excellence and regulatory compliance at Thermo Fisher Scientific while supporting a culture of continuous improvement.

+ Collaborate with cross-functional teams to deliver high-quality products that help make the world healthier, cleaner, and safer.

+ Oversee testing operations including raw materials, in-process controls, environmental monitoring, and finished product release.

+ Support data integrity and Good Manufacturing Practices (GMP) while developing team members through mentoring and training.

+ Ensure laboratory readiness for regulatory inspections and customer audits while improving operational efficiency through quality metrics and process improvements.

Keys to Success:

Education

+ BS required, MS preferred in a scientific/technical field.

+ PhD in a scientific/technical field is a plus.

Experience

+ 6-8 years of experience in a quality position within the biological and/or pharmaceutical industry required.

+ Significant experience in supporting functional areas (e.g., PD, Manufacturing, QA, Engineering, EHS) preferred.

+ 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 supporting molecular assays (i.e. qPCR and/or ddPCR) and leading analytical method transfer activities is required.

+ Experience with regulatory inspections from the FDA, EMA, Health Canada, or other regulatory authorities required.

Knowledge, Skills, Abilities

+ 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.

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 $103,100.00–$154,700.00.

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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.