Senior Microbiologist

4 weeks ago

Ridgefield, New Jersey, United States TalentBurst Full time
Job Title: Senior Microbiologist

Join our team at TalentBurst as a Senior Microbiologist, responsible for leading the Microbiology Laboratory and microbiology studies. As a Subject Matter Expert, you will provide direction, mentoring, and complete high-level projects for the Micro team.

Key Responsibilities:
  • Exceptional knowledge of USP, EU, and ISO regulations is required.
  • Previous quality control microbiology experience in bioburden testing, membrane filtration, sterility isolator testing, conductivity, total organic carbon, endotoxin assays.
  • Basic knowledge of aseptic manufacturing environmental monitoring of Grade A-D Areas.
  • Validation protocol writing, review, and execution.
  • SOP review, creation, and approval.
  • OOS investigations writing/review and approval.
  • Mentor junior Analysts on testing, trouble shooting, and Lab-related items.
  • Ensure compliance with all cGMP standards, safety, and environmental regulations and company SOPs.
  • Provide advice to subordinates based on general policies and management guidance.
  • Ensure that high-level projects are completed on schedule and accurately.
  • Data review of EM sampling, LIMS, logbooks, and other miscellaneous lab data.
  • Participate in Change Control meetings as the Microbiology Subject Matter Expert and initiate change controls as required.
  • Support regulatory, third-party, and internal audits when required.
  • Convey complex information in a concise manner.
  • Motivate and develop teams.
  • Interact with Project Teams and cross-functional groups related to site operations.
Requirements:
  • BA/BS in Microbiology/Biology with 6-10 years of experience.
  • A thorough understanding of validation testing; write, execute, and report validation studies.
  • Practical experience in general microbiology laboratory techniques working with bacteria, yeast, and mold.
  • Prior experience with writing protocols, data review, authoring SOPs, Change Controls, out of specification investigations, and report writing.
  • Working knowledge of cGMPs in pharmaceuticals/biological/aseptic/medical device manufacturing.
  • Excellent technical writing skills.
  • Ability to collaborate effectively with personnel and between departments.
  • Strong analytical and problem-solving skills.
  • Make sound judgments from data.
  • Strong communicator.
  • Works independently.
  • Working knowledge of Word, Excel, and PowerPoint.
  • Preferred experience with a deviation/CAPA enterprise system.

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