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Manager / Senior Manager, Microbiology

7-10 years
Not Disclosed
10 Jan. 2, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Manager / Senior Manager, Microbiology
Company: Enzene
Location: Hopewell, New Jersey, United States

About Enzene
Enzene Inc. is an emerging Contract Development and Manufacturing Organization (CDMO) with a strong operational presence in India. A subsidiary of Enzene Biosciences, a leading biotechnology company, Enzene is dedicated to providing high-quality biologics manufacturing services to clients and advancing the pharmaceutical industry.

Website: www.enzene.com

Position Overview
Enzene is seeking a Manager/Senior Manager in Microbiology to lead daily operations and assist in the strategic direction of microbiology services. This role focuses on ensuring the quality and accuracy of microbiological testing, including environmental monitoring, microbial identification, and sterility assurance.

Key Responsibilities

  • Oversight: Identify risks and develop strategies to control microbiological risks in raw materials, production processes, and finished products.
  • Laboratory Management: Oversee microbiology laboratory activities including testing, method validation, equipment validation, cleaning validation, environmental monitoring performance qualification (EMPQ), microbial identification, and environmental monitoring.
  • Problem Solving: Lead investigations into out-of-specification results and environmental monitoring nonconformance. Resolve technical problems in the lab.
  • Team Leadership: Supervise and support a team of microbiologists. Provide training to ensure personnel are proficient in microbiological procedures.
  • Compliance: Ensure all laboratory activities adhere to GMP and regulatory requirements. Oversee CAPAs, deviations, and change controls within the Microbiology group.
  • Documentation: Develop, review, and update SOPs, protocols, and reports related to microbiological testing.
  • Data Management: Manage and store microbiological data, ensuring accuracy, security, and retrievability. Analyze data to identify trends and areas for improvement. Familiarity with LIMS for data tracking is preferred.
  • Audit & Client Management: Serve as the subject matter expert for microbiology during regulatory and client audits for GMP compliance.

Qualifications

  • Education: Bachelor’s Degree in Science or a related field.
  • Experience: 7-10 years of experience in a microbiology laboratory leadership role within the pharmaceutical or biotechnology industry. Experience working in a GMP environment is essential.
  • Skills: Proficiency in microbial identification, environmental monitoring, endotoxin testing, mycoplasma testing, and sterility assurance. Familiarity with rapid microbiological test methods, including BacT/ALERT and mycoplasma PCR test methods, is required.

Why Join Enzene?
At Enzene, we create a collaborative and innovative environment where science and business intersect. Our team is dedicated to advancing biosimilar manufacturing and continuously striving to improve processes and patient outcomes. By joining Enzene, you become part of a company that values integrity, innovation, and collaboration in pursuit of scientific excellence.

Equal Opportunity Employer
Enzene is an equal opportunity employer committed to fostering a diverse and inclusive work environment where all employees can thrive.