Manager/Senior Manager BGC Operations in Exton

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Job DescriptionJob Description

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), 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 Benefits

Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, insurance, and life insurance.

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to , , , , , , , , status as a protected veteran, among other things, or status as a qualified individual with .

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