Quality Control Microbiology Manager
POSITION OBJECTIVE: Manage QC Microbiology personnel and laboratories. Oversee QC Microbiology testing, investigations, metrics, and product releases with continuous improvement of quality control systems.
Essential Job Functions
- Oversee Quality Control Microbiology testing for In-Process/Bulk, Finished Product, Raw Materials, and Stability.
- Review and approve laboratory data for Environmental Monitoring, Media Fill, Microbial Enumeration Testing and Sterility testing for clinical and commercial drug products.
- Setup and maintain efficient Microbiology laboratory systems and processes for increasing manufacturing output and additional sites/locations including training programs, process qualifications and gowning qualification programs.
- Recruit qualified microbiology staff for additional manufacturing site(s).
- Provide leadership, management, and career coaching for the microbiology staff.
- Establish and oversee training of QC microbiologists and manufacturing personnel on aseptic techniques and qualifications.
- Author and/or review technical documents including SOPs, test methods, protocols, validation reports, and related documents.
- Ensure a safe work environment for laboratory personnel with compliance to OSHA requirements.
- Supports testing to ensure due dates are met that are in accordance with all applicable SOPs and approved analytical methods.
- Improve process and sample flows in the laboratory for more efficient material and personnel movements.
- Conduct laboratory investigations, discrepancy investigations, environmental excursions, out of calibration reports, and CAPAs in a timely manner.
- Serve as key member of the QC organization and as a SME for microbiology while providing technical support with regards to EM issues in manufacturing.
- Prepare/approve certificates of analysis for release of raw materials, packaging components, bulk product, finished product, and contract samples.
- Review and approve analytical procedures, specifications, method and equipment validations and environmental monitoring reports.
- Provide forecast for equipment and material use to fully support future expansions and appropriately work on QC budgeting as applicable.
- Promotes and exemplifies the organization’s culture, ensuring the delivery of an exceptional customer experience with high employee engagement.
- Perform other related duties and responsibilities as assigned.
Required Education & Qualifications
- B.S. or advanced degree in Microbiology or related life science with a minimum of 5 years of experience in the pharmaceutical manufacturing industry or an Associate degree in an applicable life science with a minimum of 10 years of experience in the pharmaceutical manufacturing industry supporting sterile injectable product.
- Proficiency in the use of analytical techniques; Sterility, MET and BET testing experience is required.
- Proven capabilities in reviewing and approving analytical procedures, specifications, analytical method transfer reports, method development reports, and other technical documents.
- Strong leadership with experience in managing, supervising, and developing employees and teams.
- Ability to effectively communicate and collaborate with multiple levels within the organization to achieve measurable results.
- Strong focus on quality and safety in a laboratory environment.
- In depth knowledge and experience with cGMP 21 CFR 210/211/820 Quality Systems.
- Working knowledge of laboratory information management systems (LIMS) and experience in leading LIMS implementation and optimization.
- Advanced knowledge and implementation of data integrity principles.
- Advanced organizational and time management skills.
- Experience and involvement with regulatory inspections as well as internal and external audits.
- Experience in 5S and lean initiatives is preferred.
- Excellent verbal and written communication skills.
- Experience working with Microsoft Outlook, Excel, PowerPoint, Word, and Access
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.