iPSC Process Development Scientist

Organization
New York Stem Cell Foundation
Job Location
619 West 54th Street
New York, NY 10019
Job Description

iPSC Process Development Scientist

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 now seeking an induced Pluripotent Stem Cell (iPSC) Process Development Scientist as a key participant in this effort.

The iPSC Process Development Scientist will participate in the development of iPSC derived cell therapies for early phase clinical trials, under the supervision of the Director of GMP Process Development. The iPSC Process Development Scientist will be part of a team developing cGMP processes for bio-sample acquisition, reprogramming, iPSC differentiation, analytical quality control assays, and other lab activities.

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

Responsibilities:

  • Develop/modify original protocols for cell therapy products by application of fundamental scientific principles to pluripotent cell therapy manufacturing processes.
  • 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.
  • Develop 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.
  • Develop novel cell culture, IPSC reprogramming, and next generation differentiation steps to increase yield and process robustness.
  • Identify and 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.
  • Identify and develop assays for product characterization in collaboration with existing lab personnel, including: identity, purity, potency, and mechanism of action.
  • Contribute to CMC Master File/IMPD submissions, prepare process descriptions, and draft information for batch records. Review and approve final batch records for tech transfer.
  • Provide technical and on-the-floor support to assist in the troubleshooting of clinical drug substance manufacturing.
  • Support the 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:

  • PhD in biological sciences with 3+ years of relevant experience, or MS in biological sciences with 6+ years of relevant experience
  • At least 3 years' direct experience with pluripotent stem cell culture. Experience with iPSC reprogramming and differentiation is highly desired.
  • Excellent written, verbal, and interpersonal communication skills.
  • Demonstrated ability to work independently.
  • 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 independently and as a leader of a team of either direct reports or 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.





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