Manager, Quality Control, Microbiology, Cell Therapies

This is an exciting opportunity to join a Cell & Gene Therapy company revolutionizing cancer immunotherapies! You'll be responsible for ensuring the highest standards of Quality Control Microbiology for life-saving therapies. Lead a cutting-edge team, oversee operations with focus on environmental monitoring and microbial testing techniques (bioburden, endotoxin, gram stain, sterility). Drive GMP-regulated QC microbiology tests, ensure compliance throughout product development life cycle, including lot release, stability testing, method qualification, and validation.

Key Responsibilities:

* Lead and manage a QC Microbiology team including a Supervisor and talented analysts overseeing cGMP QC testing for lot release and stability of for life-saving drug products.

* Drive the technical transfer, qualification, and validation of microbiology test methods for in-process materials, lot release, and stability as needed.

* Spearhead the environmental monitoring program for a state-of-the-art facility, ensuring the highest standards of cleanliness and safety.

* Author, review, and approve SOPs, protocols, reports, specifications, and GMP related QC documents.

* Conduct timely trend analysis and generate comprehensive reports for environmental monitoring data.

* Take the lead in investigations for out-of-specification test results and implementing corrective actions.

* Provide vital support to product stability programs, including protocol generation, execution of stability testing, data analysis, and reporting.

* Play a key role in site contamination control programs, ensuring a safe and sterile environment for our groundbreaking therapies.

* Oversee the maintenance and development of a comprehensive microbial identification database, covering all in-house isolates from various monitoring programs.

* Collaborate on site qualification, validation, and commissioning activities as required.

* Serve as a qualified trainer to support the development of the microbiology team members.

* Foster positive relationships with internal and external partners and technical subject matter experts implementing performance management processes, routine meetings, onsite visits, and issue notification.

* Thrive in a fast-paced environment, consistently delivering high-quality and accurate results with minimal supervision.

Desired Skills & Experience

* BS or MS in Microbiology, Biology, Chemistry, Biochemistry or related Life Sciences field.

* 6+ years of BioPharma, BioPharmaceutical, Pharmaceutical or Biotechnology industry experience.

* Hands-on expertise leading QC microbiology testing and assays including sterility testing, bioburden testing, environmental monitoring, microbial identification and site contamination control testing.

* Experience leading Microbiology Supervisors and staff.

* Expertise leading microbiology related investigations with successful experience resolving related deviations.

* Experience ensuring GMP compliance, providing GMP documentation and regulatory inspection readiness.

* Expertise leading microbiology related methods development, methods qualification, and methods validation activities.

Company Description

This is an exciting new opportunity within an expanding US BioPharma company developing and commercializing novel late-stage cancer immunotherapies and Cell Therapies.