Manager/Senior Manager for Biologics, Cell, and Gene Therapy Operations (BCGT) Location: Exton, PA
Full Time
Frontage Laboratories Inc. is an award-winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, and China. Our core competencies include drug metabolism, pharmacokinetics/pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Position Summary
We 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) • 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 Benefits
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.