Title: Sr. Manager, QC Microbiology
Location: Exton, PA
Duration: Direct Hire
Schedule: M-F Full Time
Target Start Date: ASAP
This position will manage the Microbiology laboratory operations on a daily basis in the Biologics Pilot Plant. The position oversees microbiological related testing of in-process samples, final product testing, critical utilities sampling and testing, validation and requalification support, incoming component testing, and microbiological identification in the biologics pilot plant, in support of commercial and clinical product manufacturing. Sampling and testing must meet or exceed ICH, FDA, PMDA, EMA, and other governmental regulations or guidelines. This position oversees all raw material and final product (BDS and antibody drug intermediate ( ADI)) testing conducted at contract laboratories. The Sr. Manager QC Microbiology is responsible to act as the functional subject matter expert during regulatory inspections. The person leads, develops and mentors staff at a variety of levels.
This position provides leadership, management, and delivery of compliant laboratory data in support of clinical and commercial material manufactured in the Biologics Pilot Plant, in accordance with appropriate regulatory, corporate and scientific guidelines.
Manage Daily operations of the QC Microbiology laboratory, to ensure adherence of sampling and testing operations to cGMP (including data integrity), ICH, FDA, EMA and PMDA regulations and Guidelines, industry standards, and OSHA requirements. Oversee internal microbiological testing for product, raw materials, critical utilities, and environment. Monitor sample collection, testing, and data review. Provide routine trend analysis and reports to upper management.
Validation and requalification support.
Oversee all external testing for raw materials and BDS / ADI performed at contract laboratories. Monitor sample collection, testing, and data review.
Manage, recruit, train, and develop staff supporting operations. Ensure staff are trained in specific job knowledge, equipment operation, and relevant regulations. Provide supervision and hands-on support of laboratory staff in the operation of equipment and assays to support operations. Coordinate maintenance, calibration, and validation with appropriate internal departments.
Conduct and manage laboratory investigations and participates as QC representative during investigations into deviations/exceptions as required. Provide timely reporting, investigation, and resolution of deviations, change control, and corrective and preventive actions.
Interact cross-functionally with Upstream and Downstream Operations, Support Operations, Facilities, QA, QC Biochemistry, Validation, and other internal and external functions to support successful product development and commercial / commercialization activities.
Plan and implement process improvement and cost reduction activities at the departmental and inter-functional level. Develop and oversee facility-wide programs to help ensure product quality.
Development and management of SOPs, forms, and methods required to support the compliant operation and testing conducted in the Microbiology laboratory.
Ability to lead and maintain the development of Microbiology laboratory testing data and trending.
Scheduling of Microbiology laboratory personnel within the department to meet the Manufacturing schedule and needs.
Requirements: BS/BA in Microbiology, or other relevant scientific discipline required.
A minimum of 8 years' working experience in a cGMP Quality Control department within an FDA-regulated industry required
Minimum 3 years' direct supervisory experience required.
Experience with aseptic processing or bioprocessing is required.
Advanced data integrity knowledge and practices. Intermediate understanding of statistics, control charts, action and alert limits.
Thorough knowledge of cGMP/ICH/FDA regulations.
Intermediate knowledge of Good Engineering Practices and Validation Principles: URS, IQ, OQ, PQ, PPQ, etc.
Experience with inspections/audits by the FDA or other similar regulatory agencies.
Ability to prioritize and successfully manage complex and competing projects.
Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision- making skills.
Must be team-oriented and has the demonstrated ability to work cross-departmentally throughout the manufacturing site.
Demonstrated resource management and planning skills. Must be flexible, adaptable, and able to work under pressure while meeting designated timelines.
Experience with LIMS preferred.
Physical requirements: Limited handling of laboratory equipment, chemicals, and biological material
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.