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