| Job Description | StemCells, Inc. is engaged in the research, development, and commercialization of cell-based therapeutics and tools for use in stem cell-based research and drug discovery. The Company’s lead therapeutic product candidate, HuCNS-SC® cells (purified human neural stem cells), is currently in development as a potential treatment for a broad range of central nervous system disorders. Clinical trials are underway in Spinal Cord Injury and dry Age-related Macular Degeneration. StemCells also markets a range of stem cell research products under the SC Proven® brand, and offers contract cell process development and production services.
We are currently seeking an Assay Methods Development Scientist. This position will lead the development efforts of analytical control methods for use in our GMP manufacturing operations and the progression to pivotal trials and commercialization.
Responsibilities include:
1. Develop, qualify and validate new test methods as required by the product development programs. Such assays may include:
a. In vitro characterization of cell biology, function and differentiation
b. Multi-parametric characterization of cell-based product potency
c. FACS-based characterization of cell phenotype, function and differentiation
d. Physical, chemical, biochemical, FACS, and/or molecular biological characterization of bulk intermediate and conjugated final antibody products for use in the manufacture of cell-based therapeutics
e. Physical, chemical, biochemical, FACS, and/or molecular biological characterization in-process and final product stability samples of cell-based therapeutics
f. Rapid sterility test methods
2. Write SOPs, methods development, qualification and validation protocols, reports and other documentation
3. Execute methods development, qualification and validation protocols
4. Orchestrate and manage the transfer of assays from research into development and from development into the QC environment
5. Liaise and coordinate with research, development, manufacturing, QA, regulatory and clinical groups to ensure that product development timelines and objectives are met
6. Other duties as may be assigned
StemCells, Inc. offers a comprehensive and competitive compensation package, as well as generous paid time off in addition to Company observed holidays, and Medical, Dental and Life Insurance. We promote a culture in which employees are respected and rewarded for hard work, innovation, personal initiative, and teamwork. |
| | Company | | StemCells, Inc | Job Code | | State or Province | | California | | |
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