Manager/Senior Manager for Biologics, Cell, and Gene Therapy Operations (BCGT)Location: Exton, PAFull TimePosition SummaryWe are seeking a highly experienced CMC Quality Control (QC) leader to support biologics and gene therapy CMC programs in a contract research laboratory environment. The focus of the role is to closely collaborate with scientists from multi-disciplinary teams and to ensure Frontage consistently provides high quality of work for its clients.
This position requires strong expertise in phase-appropriate CMC QC strategy, analytical method lifecycle management, and regulatory compliance, along with the ability to operate effectively in a multi-client, fast-paced CRO setting.
Key Responsibilities- Lead and oversee QC activities supporting biologics and gene therapy programs in all phases
- Lead method development, qualification, validation, verification, and transfer
- Author/review/approve validation protocols, reports, and analytical data packages
- Oversee deviations, OOS/OOT, CAPAs, change control, and data integrity investigations
- Support regulatory inspections and client audits as CMC QC subject matter expert
• Train and develop staff scientists
• Manage budgets and balance resource allocation to meet project priorities.
• Closely interact with clients through various means of communication and ensure client satisfaction.
Education Requirements- BS, MS, or PhD in Biological Sciences, Biochemical Engineering, Chemistry, or related disciplines.
Required Experience - More than six years of experience in GMP testing and analytical development for biologics and/or gene therapy products.
- Expertise in at least one of technical areas, such as binding assay (ELISA, SPR, BLI, etc.), potency assay (cell based), molecular biology (qPCR and dPCR), and separation sciences (RP-HPLC, HIC, HILIC, SE-HPLC, IEX, icIEF, and CE-SDS, etc.)
- Knowledge of general GMP laboratory operations, method transfer, qualification, and validation.
- Knowledge of FDA, EU, USP, ICH guidelines and regulations
- Excellent communication skills for liaising and communicating with vendors, customers, and internal departments.
- Able to quickly assess compliance risk of events and make decisions that are scientifically sound and compliant with the regulations.
- Ability to collaborate effectively in a dynamic and cross-functional matrix environment.
- Experience with ZENQMS and laboratory information systems, such as NuGenesis, is plus.
Salary and BenefitsFrontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
