QC Senior​/Principal Scientist, Analytical Method Validation

QC Senior/Principal Scientist, Analytical Method Validation

Lexington, MA

The QC Senior/Principal Scientist for Analytical Method Validation is a key role within our Quality Control Technical Services (QCTS) department within our CDMO facility. The individual will work collaboratively with new and current clients, analytical development team, quality control, manufacturing and quality assurance. Lead transfer and validate next generation analytical procedures for the testing of viral vectors, cell banks and gene therapy products in support of Genezen’s services and commercial products in compliance with company policies and procedures and regulatory guidelines.

• Ability to work in a fast-paced, collaborative environment, working with minimal direction and able to manage workload based on changing priorities.
• Work independently and is responsible for optimization, qualification, transfer and validation of analytical methods associated with cGMP production.
• SME for cell-based and analytical method protocols and reports related to QC Method transfer, qualification, feasibility and validation.
• Perform statistical analyses of data generated during method validation studies, qualification and critical material qualification.
• Responsible for monitoring analytical method performance, including assessment of analytical method system suitability requirements.
• Present to cross-functional teams and effectively communicate critical analytical issues and solutions.
• Coordinate with Critical Material Sr. Scientist to design and qualify critical materials required for cell based methods to support phase appropriate readiness
• Support cGMP operations, including generation of documentation in support of change controls and corrective actions/preventative actions, deviations, out-of-specification (OOS) results, and other investigations or assay troubleshooting.
• Subject matter expertise in product quality attribute methods relevant to gene therapeutic product (e.g. cell function characterization assays, HPLC, ddPCR / qPCR, ELISA, Potency Assay, plate-based assays, CE-SDS, SDS-PAGE and western blot) and/or viral vector manufacturing.
• Familiar with FDA and EMA guidance documents relevant to gene therapy.
• Working knowledge of quality systems requirements.
• Demonstrated leadership skills and the ability to collaborate with and effectively influence others.
• Interface with clients and Genezen cross-functional teams to define technical requirements and provide routine project updates.
• Assure that laboratory procedures are current and facilitate updates as required
• Provide coaching to QCTS scientists and develop and contribute to their technical development
• Lead training of new analytical methods and support QC analysts on execution, data analysis and technical review of data generated in GMP lab.
• Complete documentation in accordance with current Good Manufacturing Practices (cGMP).
• Identify, lead, and/or support continuous improvements to current processes/procedures accordingly for increased compliance and efficiency
• Support onboarding and qualification of new instruments in cGMP laboratory environment.

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

Ph.D or MS in Molecular Biology/Biochemistry or other related Life Sciences

Minimum 8 years of analytical laboratory experience in GLP/cGMP environment ideally associated with analytical method validation and transfer.

Prior experience with analytical method validations, analytical data trending/statistical analysis

Understanding of QC instrument qualification is preferred.

Thorough understanding of industry testing requirements/standards

Preferred experience with performing cell based bioassays using mammalian cell-lines (such as HELA, HEK-293, Huh-7 etc.) along with QC instrument qualification is essential.

Thorough understanding of industry testing requirements/standards related to gene/cell therapy products.

Familiar with ICH, FDA and EMA guidance documents relevant to…