Genezen · 15 hours ago
QC Senior/Principal Scientist, Analytical Method Validation
Lexington, MA
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expGenezen is a company focused on gene therapy, providing process development and GMP viral vector production. The QC Senior/Principal Scientist for Analytical Method Validation will lead the validation of analytical procedures for testing viral vectors and gene therapy products, ensuring compliance with regulatory guidelines.
BiotechnologyGeneticsManufacturing
No H1B
U.S. Citizen Only
Responsibilities
Ability to work in a fast-paced, collaborative environment, working with minimal direction and able to manage workload based on changing priorities
Works 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
Qualification
Required
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
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 gene/cell therapy
Computer/software literacy (MS Word, Excel, JMP, Minitab, and LIMS etc.)
Ability to thrive in a quickly changing, CDMO environment where flexibility and teamwork is essential
Ability to work in a fast-paced, collaborative environment, working with minimal direction and able to manage workload based on changing priorities
Proven demonstration of technical writing skills such as protocol, reports, procedures etc
Preferred
Understanding of QC instrument qualification is preferred
Thorough understanding of industry testing requirements/standards
Working knowledge of quality systems requirements
Effective project management and presentation skills
Good/effective communication and organizational skills with the ability to work well with others and independently
Ability to work collaboratively with cross functional departments
Benefits
Paid vacation days, amount based on tenure
Paid sick time
10 observed holidays + 2 floating holiday + 1 volunteer day
401(k) plan with company match up to 6% of salary, vested immediately
Share Appreciation Rights
Choice of several healthcare plans
FSA and HSA programs
Dental & vision care
Employer-paid basic term life/personal accident insurance
Voluntary disability, universal life/personal accident insurance
Accidental Death & Dismemberment (AD&D) Insurance
Company
Genezen
Genezen offers contract process development, GMP viral vector production, transduced cell manufacturing, and testing services.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$18.5MKey Investors
Ampersand Capital Partners
2023-11-02Series Unknown· $18.5M
Leadership Team
Steven J. Favaloro
Chairman & CEO
Michael Wourms
Chief Operations Officer
Recent News
Precedence Research
2025-11-27
Company data provided by crunchbase