Senior Quality Control Scientist - Stem Cell

Are you passionate about Quality Control, with expertise in Molecular Biology, Cell Biology, or Stem Cell Biology? Do you have significant industry experience in Quality Control for Advanced Therapies, particularly within Cell and Gene Therapy?

If so, this could be a unique opportunity for an ambitious individual to join a rapidly growing organization focused on cutting-edge stem cell innovation.

The Role:

As a Senior Scientist, you will report to the Associate Director of QC & GMP Analytical Development and will be responsible for implementing QC testing for cell banks, starting materials, drug substance, and drug product to support clinical manufacturing of a cell therapy candidate. This is an exciting opportunity to contribute to the development of next-generation cell therapies, collaborating with teams across quality, regulatory, and CMC.

Key responsibilities include:

1. Leading method transfer, establishment, and qualification of assays for QC release of a novel engineered cell therapy, including flow cytometry, ddPCR and/or qPCR, and cell-based functional assays.
2. Participating in the selection of contract testing organizations (CTOs) and contract development and manufacturing organizations (CDMOs) for analytical methods required for testing starting materials, drug substance, and drug product.
3. Collaborating with the analytical development team to ensure method readiness for transfer to GMP testing labs.
4. Working with quality assurance and regulatory teams to incorporate current regulations and guidance into the testing approach.

Skills and Experience Required:

1. Strong experience in Quality Control, ideally within a Biologics, Cell Therapy/ATMP, or Biopharmaceutical organization.
2. Solid understanding of qPCR or ddPCR.
3. Educational background in Molecular Biology, Cell Biology, Biological Science, Stem Cell Biology, or a related field.
4. Excellent communication skills and the ability to work with individuals at all levels.
5. Proactive, driven, pragmatic, open-minded, emotionally intelligent, and respectful approach to work.

Benefits:

1. Competitive salary.
2. Opportunity to work on cutting-edge therapies and technologies in a growing field.
3. Dynamic, cross-functional work environment that encourages collaboration.

This is a permanent position offering the chance to contribute to the development of next-generation cell therapies in a fast-paced, innovative environment.