IPSC Process Development Associate

nyscf

IPSC Process Development Associate

New York, NY
Paid
  • Responsibilities

    IPSC PROCESS DEVELOPMENT ASSOCIATE

    The New York Stem Cell Foundation (NYSCF) is a rapidly growing and highly successful nonprofit whose mission is to accelerate cures through stem cell research. We are a vibrant organization that advances cutting-edge stem cell research in our own laboratory and through the support of talented scientists at other institutions.

    NYSCF is now translating its research directly into the clinic and as such is seeking an INDUCED PLURIPOTENT STEM CELL (IPSC) PROCESS DEVELOPMENT ASSOCIATE as a key participant in this effort.

    The IPSC Process Development Associate will participate in the development of IPSC derived cell therapies for early phase clinical trials as part of a team developing cGMP processes for biosample acquisition, reprogramming, IPSC differentiation, analytical quality control assays, and other lab activities.

    The IPSC Process Development Associate is a full time position, located at the NYSCF Research Institute in New York, NY.

    RESPONSIBILITIES:

    • Execute established protocols for cell therapy products development by applying fundamental scientific principles to pluripotent cell therapy manufacturing processes (tissue processing, expansion, reprogramming, cell culture, downstream differentiation, isolation, formulation, sterile filling, cryopreservation, etc.).
    • Execute studies based on Quality by Design (QbD) principles (including FMEA and DOE) for identification of Critical Quality Attributes, Critical Process Parameters, ranges and criteria for IPSC and differentiated cell therapy products.
    • Follow established procedures and methods related to the production of live cells at both bench and manufacturing scales; identify equipment and components necessary for scale GMP production.
    • Ability to work with novel cell culture, IPSC reprogramming, and next generation differentiation protocols to increase yield and process robustness.
    • Willingness to implement necessary changes to existing processes and reagents for GMP compliance.
    • Execute technology transfer projects, resolve processing issues, and conduct technical assessments on process/product impact due to changes in equipment, scale, and raw materials.
    • Contribute to the development of assays for product characterization in collaboration with existing lab personnel, including: identity, purity, potency, mechanism of action and functional assays.
    • Contribute to CMC Master File/IMPD submissions.
    • Write batch records for tech transfer.
    • Provide on-the-floor support to assist in the troubleshooting of clinical grade cell line manufacturing.
    • Support GMP manufacturing process.
    • Maintain accurate and complete development records and protocols.
    • Communicate in written and oral form with a multidisciplinary team including: Investigators, Scientific Staff, Quality Assurance, Manufacturing, Operations, R&D, etc.

    MINIMUM JOB QUALIFICATIONS:

    • Bachelors or Masters degree in Biology/Biochemistry or other relevant field with 1-3 years experience in the field of pluripotent stem cell biology and/or cell therapy.
    • At least 1 year direct experience with pluripotent stem cell culture. Experience with IPSC reprogramming and differentiation highly desired.
    • Excellent written, verbal, and interpersonal communication skills.
    • Demonstrated ability to work in a team.
    • Able to analyze and interpret data.
    • Be a self-starter with the ability to take on several projects at one time.
    • Excellent critical thinking, organizational, and analytical skills.
    • Highly motivated, with the ability to work in a team of matrix-project based reports.
    • Adaptability to work in a fast-paced and changing environment.

    NYSCF is an Equal Opportunity Employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status