What are the responsibilities and job description for the Lead Scientist, QC Assay Validation position at Thermo Fisher Scientific?
Thermo Fisher Scientific’s Viral Vector Services (VVS) is a rapidly growing, dynamic gene therapy contract development and manufacturing organization (CDMO) that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future.
How will you make an impact?
A Lead Scientist, QC Assay Validation provides technical expertise for analytical method transfer and lab equipment qualification activities at the Plainville site. These activities include the qualification/validation of analytical methods and related equipment for support of cGMP manufacturing. Transfer of assays from external clients and internal business partners, such as MST/ADA/FL QC, to the Plainville QC testing laboratory. The lead scientist is the main point of contact for clients and is the primary technical interface for the client's technical staff. The lead scientist coordinates with QC team to implement required technical transfer, method qualification and validation activities, while ensuring all timelines and external partners expectations are met.
What will you do?
- Responsible for method transfer from clients and internal sites, method comparability, and training of analysts.
- Work closely with the Manager of QC and team members to ensure compliant and phase appropriate implementation of new methods.
- Develop, revise and review SOPs, test methods, qualification/validation protocols and reports.
- Responsible for qualification and maintenance of new and existing laboratory equipment.
- Ensure readiness of the QC Validation team for all audits/inspections.
- Participates in audits and inspections as QC Validation SME and ensures "on time" completion of all related commitments.
- Provide oversight of method qualification and validations.
- Ensure required protocols, equipment and method documentation, analyst training, and laboratory timelines are in place for qualification/validation activities.
- Handle any qualification/validation deviations according to site procedures.
- Review qualification/validation data and archive all related documents.
- Evaluate the functional strengths and weaknesses in the QC analytical organization and drive continuous improvement.
- Participate in the evaluation and introduction of new analytical technologies from ADA and MST.
How will you get here?
- PhD molecular biologist or biochemist with 5-7 years of Quality Control experience or MS with 7 – 9 years of Quality Control experience in the biotech and/or pharmaceutical industry
Knowledge, Skills, Abilities
- The ideal candidate will be proficient in Molecular, Viral, Cell and Tissue Culture operations and principles.
- Experience leading method qualification and technical transfers.
- Prior use of quality systems (Trackwise, LIMS, etc) and understanding of regulatory requirements (ISO, CFR, etc)
- Prior experience in external regulatory inspections (e.g. FDA, MHRA)
- Extensive experience working with GMPs, SOPs and quality control processes
