Position: Supervisor Microbiology and Environmental Monitoring (EM) Laboratory
Department: Quality Control
The Supervisor of EM is responsible for overseeing activities related to the EM laboratory at the CEL-SCI manufacturing facility under current Good Manufacturing Practices (cGMP). The Supervisor of EM reports directly to the Manager of Environmental Monitoring.
Education and Experience:
- B.S. or M.S. in Microbiology, Biology, Biotechnology, or other related discipline.
- At least five (5) years of experience in a microbiology laboratory in the Biotechnology, Biopharmaceutical or Pharmaceutical industry working with GMP. Specific experience should include but not limited to: EM sampling, aseptic processing, process water sampling and testing, microbial identification, Sterility testing, Bioburden analysis, clean room operations, EM data analysis and trending.
- At least one (1) year in a supervisory position of a microbiology laboratory in the Biotechnology, Biopharmaceutical or Pharmaceutical industry working with GMP
- Experience with injectable drugs, preferred
The successful candidates must be a hands-on supervisor. The candidate must be able to perform (at minimum) and be proficient in the following:
- Supervise technicians
- Supervise / perform and participate in the qualification of Environmental Monitoring of the facility [e.g., viable and non-viable sampling (air, surface, and water)]
- Write and revise scientific documents, protocols, reports and SOPs
- Experience in performing trend analysis (experience working with MODA-EM software system would be an advantage)
- Represent the QC department in the in-house EM excursion investigation program
- Analyze samples using appropriate instrumentation (e.g., TOC, Conductivity & pH)
- Perform Microbial Limit Testing
- Maintain media inventory and assure media needed for all routine testing is available at the time needed
- Establish and perform the in-house microbial ID program
- Follow established laboratory safety procedures
- Have excellent knowledge of GMPs, ICH and EU/EC regulations
- Have knowledge of compendial procedures and guidance documents (i.e., USP, NF, EP, JP)
- Have good written and oral communication skills
Position is full time. Weekend, holiday, and evening work to be assigned on a rotating basis, as needed.
Limited local travel to other Company facilities may be required.
We offer competitive salaries, outstanding comprehensive benefits, and Employee Stock Options.
Please submit cv/resume to firstname.lastname@example.org. Reference the job title in the subject line of the email
CEL-SCI Corporation is committed to a policy of equal employment opportunity. CEL-SCI will recruit, hire, train, and promote into all job titles the most qualified individuals, without regard to race, color, creed, protected veteran status or disability, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.