Job Description
• Help with operational start-up of a new CART process development lab space
• Participate in information/ tech transfer from external collaborator and implementation of CART processing technologies (T-cell isolation, activation, genome-engineering, expansion, cryopreservation, and supporting/ associated analytical characterization methods)
• Contribute to relevant and impactful innovation programs to enhance CART manufacturing technologies/ capabilities and work-processes (such as alternate transfection/ cell engineering strategies, media development, disposable/ closed production systems and automation) as needed/ appropriate.
• Work closely with Project Team and key partners - communicate and collaborate effectively to ensure seamless interfaces and interactions with all stakeholder groups
• Apply scientific and technical experience to establish safe, high-quality lab practices, and demonstrate strong personal leadership and technical and interpersonal skills
• Ensure high-quality, timely documentation in electronic laboratory notebooks and contribute to and Technical Reports as appropriate.
Qualifications
• PhD degree in Molecular Immunology/ Molecular Biology or related field or Chem. Engineering degree (with appropriate bioprocessing, cell and gene therapy focus) with 4+ years of postgraduate experience (or MSc with 7+ years) in biotech/ bio-pharma industry (preferably in the development and characterization of manufacturing processes for cell- or gene-based therapies).
• Process development for GMP bio-manufacturing (DOE, media development, disposable processing technologies, automation - prior experience with cell- or gene-therapy process development preferred)
• Relevant cell and molecular biology experience such as production/ characterization of recombinant viruses or growth and molecular engineering of primary T cells.
• Familiarity with cGMP and relevant Regulatory Guidance documents.
• 1-3 years of experience in Cell/Tissue Culture.
Additional Information