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Laboratory QA Manager

3 months ago

Florham Park, New Jersey, United States Celularity, Inc. Full time

Job Title: Laboratory Quality Assurance Manager for Clinical and Commercial Pharmaceuticals at Celularity Inc.



About Celularity:
Celularity Inc., headquartered in Florham Park, N.J., is a biotechnology company specializing in developing off-the-shelf placental-derived allogeneic cell therapies for cancer, immune, and infectious diseases.

Job Description:
As the Laboratory QA Manager, you will ensure the accuracy and reliability of test methods for biological and medical device products.

Responsibilities:
  • Provide Quality oversight for analytical methods in clinical trials and commercial production.
  • Ensure compliance with regulatory guidelines.
  • Review and approve validation protocols and reports.
  • Stay updated on regulatory requirements and industry standards.
  • Identify and mitigate risks associated with validation activities.
  • Drive continuous improvement initiatives for method validation processes.
  • Review and approve method-related issues.
  • Present laboratory-related metrics at management meetings.


Requirements:
  • Bachelor's degree in Microbiology, Biology, Pharmacy, or related field.
  • 5+ years of experience in method validation.
  • Strong understanding of regulatory requirements.
  • Demonstrated leadership experience.
  • Excellent analytical and problem-solving skills.
  • Proficiency in biological assays.
  • Excellent communication and interpersonal skills.
  • Knowledge of electronic Document Management Systems preferred.
  • Strong knowledge of Quality Risk Management preferred.

Working Conditions:
  • Office environment with occasional visits to laboratories.
  • Flexible scheduling and some light lifting may be required.
  • Gowning aseptically may be necessary.


This job description is a snapshot of the role and does not encompass all responsibilities. Employees/contractors in this position may be required to perform additional duties as needed. Must be eligible to work directly for Celularity in the U.S. Celularity Inc. is an equal opportunity employer.