MICROBIOLOGY SUPERVISOR CordenPharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical, and biotech companies manufacture medicines with the ultimate goal of improving people’s lives. Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being. OUR PEOPLE VISION We strive for excellence. We share our passion. Together, we make a difference in patients' lives. SUMMARY: The Microbiology Supervisor is responsible for leading daily microbiology laboratory operations within a GMP-regulated pharmaceutical environment. This role oversees environmental monitoring programs, Environmental Monitoring Performance Qualification (EMPQ) activities, and water system testing programs, ensuring all microbiological testing is completed accurately, on schedule, and in compliance with applicable regulatory requirements. The supervisor is responsible for the development, execution, maintenance, and continuous improvement of environmental monitoring and contamination control programs, including cleanroom qualification and requalification activities. This position manages trending and evaluation of microbiological data, establishes and maintains alert and action limits, and leads investigations related to deviations, OOS, OOT, environmental monitoring excursions, and water system excursions. The role also supports the qualification, monitoring, and maintenance of cleanrooms, controlled environments, and pharmaceutical water systems. In addition, this position provides leadership and training to microbiology staff, manages laboratory inventory and supplies, and collaborates closely with Quality Control, Quality Assurance, Manufacturing, Engineering, and Validation teams to support product release, stability testing, facility qualification projects, and continuous improvement initiatives.
The ideal candidate will possess strong technical microbiology expertise, including environmental monitoring program qualification (EMPQ), contamination control strategies, and cleanroom operations, along with a thorough understanding of cGMPs, FDA regulations, EU GMP Annex 1, and ICH guidelines. Strong communication, organizational, problem-solving, and leadership skills are essential for success in this role.PRIMARY RESPONSIBILITIES:
QUALIFICATIONS:
ADA - THESE REQUIREMENTS ARE A CONDITION OF EMPLOYMENT:
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| Location | North Augusta, South Carolina |
| Website | https://www.ambiopharm.com |
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