QC Manager, Bioanalytical

Work Schedule

Environmental Conditions

Job Description

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.

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.

The Manager, Quality Control Bioanalytical & Analytical Transfer provides leadership and scientific and technical expertise for bioanalytical QC and transfer activities at the Plainville, Massachusetts site. These activities include the timely qualification of in-process and release testing of toxicological, clinical, and commercial grade biopharmaceuticals, qualification/validation of analytical methods for support of cGMP manufacturing, and the transfer and validation of assay methods from clients and/or Assay Development & Analytics to the cGMP QC testing laboratory.

The manager ensures cGMP compliance, operates within budgets, and supervises bioanalytical lab staff directly and QC scientists and technicians indirectly. Responsibilities include hiring, training, goal setting, and performance evaluation. The manager collaborates with departments and project teams for planning and timelines, improves QC services, and maintains safe working conditions. Additionally, the manager serves as the primary technical liaison with clients.

• 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.

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

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

• 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 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.

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.