Biologics & Gene Therapy QC Manager — CMC Leader

Frontage Laboratories, Inc.; Exton, Northern (PA, KY); Hybrid; USD 120,000 - 150,000; Full time

Benefits offered by this job

Health and dental insurance

401(k) plan

Disability insurance

Life insurance

Job summary

Frontage Laboratories Inc. in Exton, PA seeks a Manager/Senior Manager for Biologics, Cell, and Gene Therapy Operations (BCGT).

This CMC QC leadership role collaborates with scientists to ensure high quality work for clients in a fast-paced CRO. Responsibilities include leading QC activities, developing and validating analytical methods, reviewing validation reports, and ensuring data integrity, CAPA, and regulatory readiness.

Qualifications

• BS, MS, or PhD in Biological Sciences, Biochemical Engineering, Chemistry, or related disciplines.

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.

Skills

CMC QC leadership

Analytical method development

Regulatory compliance

GMP knowledge

Cross-functional collaboration

Communication skills

Education

BS/MS/PhD in Biological Sciences or related

Tools

NuGenesis

ZENQMS

LIMS

Job description

Frontage Laboratories Inc. in Exton, PA seeks a Manager/Senior Manager for Biologics, Cell, and Gene Therapy Operations (BCGT).

This CMC QC leadership role collaborates with scientists to ensure high quality work for clients in a fast-paced CRO. Responsibilities include leading QC activities, developing and validating analytical methods, reviewing validation reports, and ensuring data integrity, CAPA, and regulatory readiness.