This role will be responsible to provide leadership and oversee cell biology and cell culture laboratories for The Discovery Labs. This individual will be a key member of the team with responsibilities to develop, produce and maintain all internal and client cell banks, cell maintenance and support live cell assays. Have a strong understanding and demonstrated expertise with cell culture technologies, method development/qualification/validation, and GMP testing. Functions will include but are not limited to: the development, qualification and validation cell based methods for GMP release of cell therapies and vector technologies in partnership with the analytical services labs, the technology transfer of methods from clients, establishing and maintaining cell lines to assure method reliability through development and GMP testing.
● Lead development of creation of cell banks and characterization studies to qualify cell banks for GMP testing activities.
● Manage and provide subject matter expertise to a team of scientists to support multiple VCGT cell-based programs
● Lead development of cell biology program plans in conjunction with relevant stakeholder and Sr. management as well as oversee their execution to meet strategic objectives
● Monitor and report on project progress, write analytical development protocols and reports, provide recommendations to senior management
● Identify, qualify and manage analytical reagents as per regulatory standards
● Establish reference standard materials as required to support assay validation.
● Train and transfer assays to Testing groups or third-party vendors.
● Collaborate with testing, process development and manufacturing functions to ensure strong cross functional collaborations and integrated process and product development and characterization
● Author, review and/or approve key documents such as: comparability protocols and reports, and relevant sections of regulatory filings (IND, IMPD, BLA, etc.)
● Assure all laboratory documentation and other regulatory compliance systems are maintained according to corporate standards
Education & Experience
• MS in cell biology or related discipline with 8+ years of industry experience in cell culture / cell based analytical methods, plus 5 years management experience or BS / BA with 10+ years will be considered
• Previous experience leading a team of scientists
• Proven experience with the culture of multiple mammalian cell lines
• Demonstrated abilities in mammalian cell culture, live cell assays and methods including transfection, cryopreservation and biosafety procedures.
• Deep practical knowledge of analytical development requirements, regulatory guidance
• Good understanding of statistical methods requirements for study design and data analysis
• Technical proficiency in operation and user training of standard cell biology laboratory equipment including microscopes, plate readers, flow cytometers, liquid handlers and centrifuges.
• Excellent organizational, technical, and trouble-shooting skills with attention to detail.
• Capacity of working independently as well as collaboratively as part of the project team
• Excellent written and verbal communications skills, and the ability to present and defend positions and approaches critical to program progression and success
• Strong knowledge of GMP, GLP, ICH and other regulatory requirements for biological product characterization and release assay qualification.