Microbiology Supervisor

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:

• Supervises all Microbiology related activities.
• Responsible to maintain schedule and perform testing for weekly, monthly, and quarterly testing for Water systems as well as clean rooms.
• Maintain trending data for routine water testing and environmental monitoring of the clean rooms.
• Must be able to lead/assist with microbiology related investigations, including but not limited to, Alert and Action Limits, Out of Specification, Out of Trend, and Deviations.
• Responsible for procurement of Micro/QC lab supplies used for testing.
• Train and supervise microbiologist on different methodology used within microbiology lab.
• Assist the QC/QA group with writing and editing SOPs and STPs
• Ensure timely execution/testing of micro related stability and product release samples.
• Support and perform microbiology related activities for qualification/ maintenance of water system and clean rooms.
• Other duties as required by Quality Control or Microbiology Management.
• Serve as site subject matter expert (SME) for Environmental Monitoring Program Qualification (EMPQ), contamination control, cleanroom monitoring, and water system microbiology.
• Represent the Microbiology Laboratory during client audits, regulatory inspections, and quality management reviews.
• Provide technical justification for environmental monitoring strategies, sampling locations, frequencies, and limit establishment.
• Monitor changes in pharmaceutical regulations and industry standards, ensure microbiology laboratory procedures, testing methods, and quality systems remain current, compliant, and inspection-ready.

QUALIFICATIONS:

• The successful candidate must be able to work on multiple projects with a minimum of supervision and meet established timelines.
• Qualified candidate should have a BS/BA in biology /microbiology or life science with 1-5 years of experience in a GMP environment.
• Be familiar with both FR 21 and ICH guidelines in regards to GMPs. Computer skills in MS Word and EXCEL are required.
• Must possess strong interpersonal and communication (written and oral) skills.

ADA - THESE REQUIREMENTS ARE A CONDITION OF EMPLOYMENT:

• Must be able to push, pull, squat, stand and walk through-out the day
• Must be able to lift up to 50lbs
• Must be able to wear safety shoes & glasses through-out the day while in designated areas. (provided by the company)
• You must be cleared by a physician to wear a respirator throughout the day while in designated areas.
• Must be able work in a chemical environment.