Senior Microbiologist

4 weeks ago

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

The Senior Microbiologist is a critical member of the Quality Assurance Department at Mindlance, responsible for ensuring the highest standards of quality and compliance in the Microbiology Laboratory.

Key Responsibilities:
  • Develop and implement microbiology testing protocols and procedures to ensure compliance with USP, EU, and ISO regulations.
  • Conduct microbiological testing, including bioburden testing, membrane filtration, sterility isolator testing, conductivity, total organic carbon, and endotoxin assays.
  • Write, execute, and report validation studies to ensure the accuracy and reliability of laboratory results.
  • Mentor junior analysts on testing, troubleshooting, and laboratory-related items.
  • Ensure compliance with all cGMP standards, safety, and environmental regulations, as well as company SOPs.
  • Provide advice to subordinates based on general policies and management guidance.
  • Lead high-level projects to ensure timely completion and accuracy.
  • Review and analyze laboratory data, including 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 as needed.
Requirements:
  • BA/BS in Microbiology/Biology with 6-10 years of experience.
  • Thorough understanding of validation testing, including writing, executing, and reporting validation studies.
  • Practical experience in general microbiology laboratory techniques, including 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, and medical device manufacturing.
  • Excellent technical writing skills.
  • Ability to collaborate effectively with personnel and between departments.
  • Strong analytical and problem-solving skills.
  • Ability to make sound judgments from data.
  • Strong communication skills.
  • Ability to work independently.
  • Working knowledge of Word, Excel, and PowerPoint.
  • Preferred experience with a deviation/CAPA enterprise system.
Competencies:
  • Act for Change: Embrace change and innovation, and initiate new and improved ways of working.
  • Cooperate Transversally: Collaborate effectively with peers, stakeholders, and partners across the organization to positively impact business results.
  • Develop People: Take responsibility for developing oneself and mentor other Micro personnel in anticipation of future business needs or to assist the Micro department.
Physical Requirements:

The Senior Microbiologist must be able to lift and carry up to 20 pounds, kneel, reach, and stretch, and stand for at least 4 hours.

EEO Statement:

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.

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