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 a DIRECTOR, GMP PROCESS DEVELOPMENT as a key participant
in this effort.
The Director of GMP Process Development will manage a team to develop
cGMP processes and assays for autologous and allogeneic INDUCED
PLURIPOTENT STEM CELL (IPSC) BASED cell therapies. The Director of GMP
Process Development will be responsible for the development of cGMP
compliant processes to support biosample processing, cell culture,
reprogramming, differentiation, and other lab activities to support the
clinical development of novel iPSC based cell therapies.
The Director of GMP Process Development is a full time position, located
at the NYSCF Research Institute in New York, NY.
RESPONSIBILITIES:
- Manage a team to:
- 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, reprogramming, and next generation
differentiation steps to increase yield and process robustness.
- Identify and implement necessary changes to process 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 assays for product characterization in collaboration
with existing lab personnel, including: identity, purity,
potency, and mechanism of action.
- Lead effort in FMEA and DOE to develop experimental plan for
identification of Critical Process Parameters, ranges and criteria
for iPSC and differentiated cell therapy products. Lead and execute
the plan both personally and with a team.
- Create 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.
- Create and 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 Biology/Biochemistry or other relevant field with a minimum
of 5 years of experience in a development laboratory in the field of
cell therapy or involving cell culture.
- At least 3 years of experience in a Biotech/Pharma Process
Development and/or Manufacturing Support role for drug
substance manufacturing.
- Experience with Design of Experiment (DOE) and JMP/SPSS or other
relevant statistical software.
- Experience in transferring a development process into GMP
manufacturing, developing a tech transfer package, acting as subject
matter expert for tech transfer.
- Knowledge of FDA and EU cGMP regulations and requirements as they
relate to process and assay development.
- Experience in developing assays for transfer into a GMP testing lab.
- Understanding of cell culture processes, such as: scale up factors
from bench to clinical/commercial, metabolism profiling, influence
of raw material attributes and impact of process deviations to
growth and quality attributes, harvest and clarification processes.
- 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.