Manager, QC BioAnalytical at Thermo Fisher Scientific in Plainville, Massachusetts

Job Description:

Work Schedule

Standard (Mon-Fri)



Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)



Job Description



At Thermo Fisher Scientific team, you'll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are supported in realizing their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building an exciting and fulfilling career with us.




Location/Division Specific Information



At Viral Vector Services (VVS), a division of Thermo Fisher Scientific, 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



How will you make an impact?



The Manager, Quality Control BioAnalytical provides leadership and scientific and technical expertise for bioanalytical QC activities at the Plainville, Massachusetts site. As this is a brand-new sit, the manager will be integral in ensuring operational readiness of the lab to support GMP production. 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 vector 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 is also responsible for maintaining cGMP compliance in their areas of responsibility and for operating within project and department budgets. The incumbent serves as the direct supervisor of the bioanalytical laboratory staff, as well as the indirect supervisor of QC scientists and technicians, and supervises hiring, training, goal setting, and performance evaluation. The manager will work closely with all departments and the appropriate project teams to assist in project planning and timeline development. The incumbent will plan, implement, and coordinate the improvement of QC services, considering the application of up-to-date technical, GMP, and quality principles and ensuring safe environmental and working conditions in the QC Laboratories. The manager will handle communications with clients as a primary technical interface between the client's technical staff.




A day in the Life:

• Lead 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.


• Once the labs are operational, coordinate the day-to-day Quality Control activities for Molecular, Viral, Cell, and Tissue Culture operations and Contract testing. Seek the highest level of compliance, accuracy, and timeliness of specified testing processes. Lead efforts around bringing in new technology, equipment, methodologies, and associated validations. Provide QC leadership, guidance, and support throughout the VVS organization. Work cross-functionally and ensure good communication across the network. Ensure all testing processes, metrics, and departmental goals are met.


• 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 any required 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


• Enhancement of QC and operational metrics.


• Lead and/or support the establishment of electronic LIMS systems for the site.


• Provide frequent overall departmental feedback to senior management.


• Ensure adequate staffing is hired and trained within Bioanalytical department.

How you will get here?





Education

• BS required, MS preferred in a scientific/technical field with 8+ years of experience in a quality position within the biological and/or pharmaceutical industry.


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

Experience

• 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.


• Experience leading teams in a fast-paced environment.


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

Knowledge, Skills, Abilities

• Capable of writing reports, business correspondence, and procedure manuals.


• Strong interpersonal 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 optimally 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 handle abstract and concrete variables in situations where only limited standardization exists.


• Demonstrated knowledge of FDA and EMA regulatory requirements applicable to biologics or pharmaceuticals.


• Able to apply GMP regulations and international guidelines to all aspects of the position.

Physical Requirements / Work Environment



(Provide details)




Benefits



We offer competitive remuneration, annual incentive plan bonus, 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!


Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.



Apply today! http://jobs.thermofisher.com



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. Apply Now