Laboratory QA Manager

18 hours ago

Florham Park, New Jersey, United States Celularity Full time
About Celularity

Celularity Inc. is a biotechnology company leading the next evolution in cellular medicine by developing off-the-shelf placental-derived allogeneic cell therapies for the treatment of cancer and immune and infectious diseases.

The company is developing a pipeline of off-the-shelf placental-derived allogeneic cell therapy product candidates, including T cells engineered with a chimeric antigen receptor (CAR), natural killer (NK) cells, and mesenchymal-like adherent stromal cells (MLASCs) and exosomes.

These therapeutic candidates target indications across cancer, infectious, and degenerative diseases. Celularity believes that by harnessing the placenta's unique biology and ready availability, it will be able to develop therapeutic solutions that address a significant unmet global need for effective, accessible, and affordable therapeutics.

Job Summary

As the Laboratory QA Manager for Clinical and Commercial Pharmaceuticals, you will play a pivotal role in ensuring the accuracy, reliability, and compliance of test methods used in the development and production of biological and medical device products.

You will oversee the validation of test methods for both clinical trials and commercial manufacturing, ensuring that they meet regulatory requirements and industry standards. This role provides Quality oversight of Tissue Products (351/361) and Cell Therapy Products.

Responsibilities
  • Provide Quality oversight and approval of comprehensive method development and method validation plans for analytical methods used in clinical trials and commercial production of pharmaceuticals.
  • Partner with the method development team to provide compliance and quality guidance and support throughout the validation process, ensuring timely completion and compliance with protocols.
  • Review and approve validation protocols and reports, including method development, validation, and transfer protocols.
  • Partner with the method development team to ensure methods are suitable for their intended use and provide accurate and reliable results, using clinically phase-appropriate standards.
  • Stay abreast of evolving regulatory requirements and industry standards related to analytical method validation.
  • Identify and mitigate risks associated with method validation activities.
  • Drive continuous improvement initiatives to enhance the efficiency, effectiveness, and quality of method validation processes.
  • Perform review and approval of method-related issues on behalf of Quality Assurance, including Out of Specification, Out of Trend, Deviations, CAPAs, Method updates, SOP updates.
  • Perform regular review of Laboratory-related metrics to present at Management Review meetings and routine meetings/dashboards.
Requirements
  • Bachelor's degree in Microbiology, Biology, Pharmacy, or related field; advanced degree preferred.
  • Extensive experience (5+ years) in method validation within the biological or medical device industry, with a focus on both clinical and commercial products.
  • Strong understanding of regulatory requirements and guidelines governing method validation (e.g., FDA, EMA, ICH).
  • Demonstrated leadership experience, with the ability to effectively provide coaching and mentoring to a team of scientists and analysts.
  • Excellent analytical and problem-solving skills, with the ability to troubleshoot and resolve technical challenges.
  • Proficiency in biological assays required.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively across multidisciplinary teams.
  • Proven track record of driving results, meeting deadlines, and maintaining compliance in a regulated environment.
  • Knowledge of electronic Document Management Systems (Veeva, TrackWise) preferred.
  • Strong knowledge of ICH Q9 Quality Risk Management as it applies to phase-appropriate method development and validation preferred.
Working Conditions
  • The incumbent will be working in an office environment but will often visit and engage with manufacturing personnel in the laboratories.
  • Flexible scheduling required.
  • Some light lifting may be required occasionally.
  • Must be able to gown aseptically.

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