Manager/Senior Manager BGC Operations

Frontage Laboratories • Exton, PA

7h

About The Position

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.

Requirements

• 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.

Nice To Haves

• Experience with ZENQMS and laboratory information systems, such as NuGenesis, is plus.

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.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Ph.D. or professional degree
• Number of Employees: 501-1,000 employees