is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply. Right. On time. For more information, visit www.agcbio.com . SUMMARY:
The Quality Control Microbiology Supervisor
manages the day to day operations of the QC Microbiology laboratory including supervising QC Microbiology associates, making tactical decisions that ensure the required testing and reporting is on time and accurate. This will be a Monday-Friday, Day Shift, 8:00 am-5:00 pm or other shifts if desired. PRINCIPAL RESPONSIBILITIES:
KNOWLEDGE, SKILLS & ABILITIES:
- Supervises daily operations for QC micro team performing EM (Environmental) and CU (Critical Utility) monitoring
- Performs and oversees testing for cleaning verification to support facility product changeover
- Performs and provides training related to product, equipment, environmental and utility monitoring (EM and Product)
- Communicates clearly, efficiently and accurately with internal groups and represents QC Micro on cross-functional teams to support disruptions and investigations.
- Provides technical leadership in EM and CU monitoring and coordinates investigation, excursion and micro ID testing.
- Prepares and provides oversight of annual reports (EM, CU)
- Prioritizes and assigns project goals; ensures tasks are completed and work area goals are met
- Coordinates with other supervisors and teams to meet the business needs
- Requires knowledge of environmental and utility monitoring, compendial microbiological testing (bioburden, endotoxin), TOC and conductivity testing, investigations and report writing.
- Good organizational skills and attention to detail
- Applies understanding of how the team relates to other related areas to improve efficiency of own team
- Recognizes performance improvements and conveys feedback constructively
- Works across teams effectively
- Excellent communication and verbal presentation skills
- BS/BA degree required in Microbiology or Biology plus 5 years' industry QC experience or an MS plus 3 years' industry QC experience
- Experience supervising or mentoring staff
- Experience with GMP biologics manufacturing and related regulatory requirements including USP and EP.
- Strong understanding of Microbiology and Facility testing
- Ability to understand and evaluate analytical/technical data.
- Experience with relevant analytical lab equipment and computers.
- Clear, concise writing skills.
- Fluent in communicating (written and verbal) in English.
- Knowledgeable in Microsoft Excel and Word.
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances