Careers

Quality Control (QC) Director

Job Code: QC Dir-SCI

Reporting to the Sr. Vice President Development & Operations, the QC Director will be responsible for all QC functions related to the Company’s product development, product manufacturing and clinical operations. Based in Palo Alto, California, this individual will organize and direct QC activities for the Company’s cellular medicine programs as well as the non-therapeutic cell technology products and service offerings at our Cambridge, UK site (e.g. the direct sales SC Proven ® Cell Culture Product business).

Responsibilities will include:

• Organization and management of the QC Department activities at the Company’s California and Cambridge, UK sites
• Establishing and managing internal QC programs and external QC testing activities carried out by contract service providers and/or contract manufacturing organizations (CMO’s) related to physical, chemical, biochemical, FACS, molecular biological and/or microbiological testing of:
• Raw materials
• Cell bank, in-process and final product samples of cell-based therapeutics
• Bulk intermediate and conjugated final antibody products
• In-process and final product stability samples of cell-based therapeutics, bulk antibody intermediate and conjugated final antibodies
• Environmental monitoring samples
• Ensuring the timely, effective and compliant performance of the QC laboratories to meet product and regulatory requirements
• Developing a motivated, informed and efficient workforce through training, mentoring, sharing of critical underpinning knowledge and other initiatives
• Liaising and coordinating with research, development, manufacturing, QA, regulatory and clinical groups to ensure that product development timelines and objectives are met
• Compiling and managing QC department budgets
• Ensuring effective use of resources and control of expenses to achieve maximum productivity and to develop and sustain robust business practices
• Compiling Validation Plans, qualification and validation protocols, reports and other documentation as required
• Up to 20% travel (domestic & international)
• Other duties as may be assigned

Candidate must possess:

• Minimum BS, MT(ASCP) or equivalent qualification
• At least 8 years of direct QC experience related to GMP manufacturing in the biotechnology industry with demonstrated leadership and senior managerial responsibility
• Expert knowledge of GLP, GMP, GTP, GCP, ISO and ICH regulations and their application
• Proven senior manager with a track record of success in organizing and leading the Quality Control functions for complex multi-faceted projects in a fast-paced operations environment
• Ability to critically analyze data, proactively solve problems and make recommendations to executive management.
• In depth knowledge of immunoassays, FACS analysis, protein analytical and characterization methodologies, mammalian cell-line characterization, molecular biology techniques, compendial test methods, USP & EP
• Excellent interpersonal skills, with a proven track record of directly and effectively interfacing with a wide variety of internal and external stakeholders at all levels
• Outstanding oral and written communication skills
• Results-oriented and adaptable; able to act independently in their area of responsibility
• Organized, multi-tasking individual
• Outstanding critical thinking and problem-solving skills

Scientist

Job Code: SCIENTIST-SCI

We are currently seeking a Scientist to work in the Stem Cell Discovery group to conduct and manage the comparative study of human stem cells derived from different starting sources. This position reports to the Vice President, Stem Cell Biology.

Responsibilities will include:

• Perform in vitro characterization of human stem cells for growth kinetics, stem cell markers and differentiation potential
• Perform in vivo analysis and evaluate engraftment, migration, differentiation and tumorigenecity potential
• Analyze results quantitatively and compile progress reports
• Interface with and communicate results to development, regulatory, clinical and senior management
• Hands-on work in laboratory as key contributor to project
• Direct supervision of research associates
• Coordinate various research activities through R&D services and animal services including animal surgeries and histology
• Other duties as may be assigned

Candidate must possess:

• Ph.D. in cell biology, developmental biology or related area
• Knowledge of and publications in stem cell biology, particularly neurobiology
• At least 3 – 5 years post graduate work
• Strong understanding and experience in stem cell biology
• Prior experience with neurobiology, neural stem cells and FACS analysis preferred
• Published work demonstrating in vitro culture and quantitative in vitro differentiation of neural cells
• Strong proven management experience working with cross functional project teams
• High standards for quality of work
• Must be flexible, mature and self motivated as well as an excellent leader and team builder

Senior Quality Assurance Specialist

Job Code: SR QA-SCI

We are currently seeking a Senior Quality Assurance Specialist. This position will support the implementation and management of the Company’s quality systems in compliance with cGMPs and other Company policies.

Job Description:

• Support the implementation and management of quality systems in compliance with current Good Manufacturing Practices (cGMPs) and company policies
• Perform compliance review of the batch records for both in-house and externally manufactured products including in-process testing results, final QC release testing results, labeling/packaging and all supporting documentation
• Perform raw material/component release
• Perform release of bulk antibody and conjugated antibody reagents for use in the manufacture of cell-based therapeutics
• Perform release of final cell-based therapeutic products for administration into human subjects
• Perform line clearance approval and act as a quality person in the plant during production operations
• Conduct investigations related to manufactured products/raw materials
• Review and approve validation/qualification packages including installation qualification, operation qualification, and performance qualification (IQ, OQ, PQ) protocols and reports
• Other duties as may be periodically assigned

Education and Experience
Candidate must possess:

• BS/BA degree in Science or equivalent
• At least eight (8) years direct QA experience related to GMP/Clinical manufacturing in the biotechnology and/or pharmaceutical industry.
• Experience in cell-based therapeutics or biopharmaceuticals is preferred.
• Strong knowledge of cGMPs
• Proven ability to work well in a multi-disciplinary project team environment
• Excellent oral and written communication skills
• Possess a strong work ethic
• Must be capable of thinking and acting independently, accepting supervision and working quickly and accurately in a fast-paced environment
• Proven ability to author, understand and follow complex written procedures
• Solid organizational, time management, problem-solving, decision-making, judgment, and interpersonal skills are critical

Veterinary Pathologist - Senior Scientist

Job Code: VET PATHOLOGIST-SCI

We are currently seeking a Veterinary Pathologist – Senior Scientist. The veterinary pathologist will design and interpret animal studies, support the validation of the development efforts to be used in future clinical studies, and lead the histology team.

Job Description:

• S erve as the primary author (with input/review by project team reps) of the regulatory preclinical research experiments
• Provide a critical, comprehensive nonclinical assessment of the stem cells engraftment and toxicologic findings, and oversee the timeline for the nonclinical sections including coordination of document reviews
• Responsible for the content, format and compliance of the dossier regulatory standards
• Develop and implement a strategy to influence internal and external nonclinical requirements for preclinical strategy
• Provide input to R & D project planning
• Provide nonclinical safety consultation and expertise
• Serve as a nonclinical safety expert on Project Teams for StemCells, Inc.
• Mentor project team representatives with less stem cells preclinical pathology and toxicology experience

Candidate must possess :

• DVM or Ph.D. with expertise in Pathology and Toxicology
• Board certification by the American College of Veterinary Pathologists (ACVP)
• 6–10 years of industry-related work experience
• E xperience level and competency in biotechnology and stem cells nonclinical research, including skills specific to crafting expert nonclinical summary documents, expertise in toxicology assessment, and experience in safety assessment of preclinical in vivo research
• Working knowledge of regulatory guidelines and practices, including a demonstrated ability to author regulatory documents of high quality, appropriate decision making regarding stem cells engraftment and selection of candidates for future development projects, ability to communicate well across business lines, and effective leadership of teams of diverse expertise
• Excellent oral and written communication skills and report-writing abilities

Senior Quality Control Analyst

Job Code: QC-SCI

We are currently seeking a Senior Quality Control Analyst to work with the Quality Control department to manage the QC release and stability testing of raw materials, in-process and final products. This position reports to the Manager, Quality Control.

Responsibilities will include:

• Prepare, test and maintain analytical reference cell banks and other reference standards for use in functional, growth promotion and cytoxicity methods for QC release and stability testing of:
• Raw materials, reagents and intermediates
• Conjugated final antibody products
• Execute QC release and stability testing of:
• Raw materials & reagents
• Conjugated final antibody reagents
• Cell banks used in the production of cell-based therapeutics
• Cell-based therapeutic final products
• Assist in the transfer, qualification and validation of test methods for identity, purity and potency (e.g. FACS; biochemical; molecular) for:
• Conjugated final antibody reagents
• Cell-based therapeutic final products
• Define, execute and report prospective stability trial programs for:
• Conjugated final antibody reagents
• Cell banks used in the production of cell-based therapeutics
• Cell-based therapeutic final products
• Co-ordinate sample distribution and results compilation for extended characterization or other informational testing with internal R&D groups and/or external vendors
• Maintain and operate QC instruments per cGMP
• Write and revise test method SOPs, test results forms, instrument SOPs and other documentation as needed
• Keep accurate and complete records per cGMP and compile trending reports as required
• Other duties as may be assigned

Education and Experience
Candidate must possess:

• College degree or BS, preferably in biological science or chemistry,
• At least eight (8) years hands-on QC experience in an FDA-regulated environment, preferably biotechnology
• Familiar with cGMP, GLP and ICH guidelines.
• Possess a strong work ethic
• Must be capable of thinking and acting independently, accepting supervision and working quickly and accurately in a fast-paced environment
• Proven ability to critically analyze data and proactively solve problems
• Good written and oral communication skills
• Proven ability to author, understand and follow complex written procedures
• Solid organizational, time management, problem-solving, decision-making, judgment, and interpersonal skills are critical
• Must have experience in cell culture and in the use of a variety of analytical instruments such as FACS analyzer, ELISA microplate readers, UV/Vis spectrometer and HPLC. Broad familiarity with techniques in molecular biology, cell biology and protein chemistry
• Familiarity with cGMP, GLP, ICH

Manufacturing Associate

Job Code: Mfg-SCI

We are currently seeking Manufacturing Associates to work in the GMP clean rooms manufacturing product for pre-clinical studies and clinical trials. This position reports to the Director, GMP Operations.

Responsibilities will include:

• Execute processes for the GMP isolation, culture-expansion and cryopreservation of stem cell and progenitor cell products for use in clinical trials according to the requirements of SOPs, batch production records and approved protocols and in compliance with GMP, GTP and ICH regulations
• Complete and Review batch production records to ensure cGMP documentation practices are followed and that information entered is complete and accurate.
• Write and/or amend SOPs, batch production records, qualification and validation protocols, reports and other documentation
• Train staff in processing methods and clean room operations
• As necessary, execute process, equipment, systems and utilities, qualification and validation protocols
• Other duties as may be assigned

Candidate must possess:

• BS, MT (ASCP) or equivalent qualification
• At least five (5) years of relevant experience either in clinical cell processing facility or GMP manufacturing operations in the cell therapy industry
• Experience with, and an in-depth understanding of, primary mammalian and/or stem cell culture, aseptic/closed system processing methods and knowledge of current GMP and GTP regulations from primary tissue processing to finished product is required
• Knowledge of flow cytometric, density gradient and immuno-magnetic separations methods for primary cell isolation and purification are desirable.
• Must be a motivated team player
• Must have excellent written and oral communication skills
• Must be willing to work flexible hours.

To Apply:

Be sure to indicate the title or job code of the position you are applying for.

Fax resumes to: 650.475.3101

Mail resume to:
StemCells,Inc.,
Attn.: Staffing
3155 Porter Drive
Palo Alto, CA 94304