Job Description

Analytical & Testing/QC Lab Manager to join a Lentiviral vector manufacturing CDMO. 

The role will drive all aspects of the Quality Control (QC) lab and is expected to have strong, hands-on, technical experience of gene therapy cell-based assays as well as characterization assays for viral vectors.

Provide leadership, scientific and technical expertise for all QC activities and is expected to work collaboratively with the team to establish and implement best regulatory, laboratory practices and lead the execution of complex experiments.

ESSENTIAL FUNCTIONS

• Maintain multiple projects and timelines
• Complete timely in-process and release testing of early clinical grade biopharmaceuticals
• Manage the QC team, including hiring, training, career, and goal development and assessment
• Maintain familiarity with current analytical and bioassay methods used for characterizing viral vectors (Assays include genome titer by Flow, ELISA, qPCR, ddPCR, genome integrity assay, empty/full particle ratio assay, sterility and endotoxin assay, and cell-based assays)
• Maintain familiarity with current equipment used in Quality Control lab
• Perform qualification/validation of analytical methods to support the cGMP manufacturing of viral vectors
• Tech transfer of bioassays from analytical development or clients to cGMP QC testing lab
• Facilitate and participate in viral vector contract development
• Serve in regulatory inspections and client audits
• Provide oversight of method qualification and validation from Assay Development and Analytics and/or clients
• Establish and maintain stability programs for clients
• Support and lead establishment of electronic LIMS systems for site
• Analyze regulatory authorities’ programs, guidance documents, and activities in areas relevant to testing of biological products

BENEFITS

• Paid vacation days, amount based on tenure, and paid sick time
• 8 observed holidays + 1 floating holiday
• 401(k) plan with company match up to 6% of salary, vested immediately
• Choice of five healthcare plans
• FSA and HSA programs
• Dental & vision care
• Employer-paid basic term life/personal accident insurance
• Voluntary disability, universal life/personal accident insurance

Qualifications

• BS in a scientific/technical discipline required

• 3-5 years of experience in a QC leadership position within the biological industry

• Proven technical leadership and experience in bioanalytical methods (method development, validation and transfer). Methods include but not limited to: ELISA, PCR, qPCR, ddPCR, cell-based assays, and flow cytometry-based assays.

+++

• MS in a scientific/technical discipline
• Familiarity with viral vector release assays
• Proven lab operations management experience
• 3+ years of cGXP experience

Additional Information

NO! AGENCIES OR 3RD PARTY AGENCIES.  WE DO NOT WORK THROUGH OTHER EMPLOYERS

US WORK ELIGIBILITY REQUIRED

Please attach a WORD resume to your submission

All of your information will be kept confidential according to EEO guidelines. EOE/Veteran/Disabled