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

Development Associate

Job Code: ProcDev-SCI

We are currently seeking a Development Associate to work with the Process Development and Assay Development Scientists to support development, qualification and validation programs for preclinical studies and clinical trials. This position reports to the Process Development Scientist.

Responsibilities will include:

• Perform material, product and/or process validation, stability, and comparability studies. Execute process and methods development, qualification and validation protocols.
• Carry out development, qualification and validation of new and existing processes and test methods as required by the product development programs. Such processes and assays may include:
• Cell culture and cryopreservation set points and limits
• In vitro characterization of cell biology, function and differentiation
• FACS-based characterization of cell phenotype, function and differentiation
• Assist with preparing SOPs, methods development, qualification and validation protocols, reports and other documentation
• Maintain laboratory equipment and inventory for pilot scale operations
• Participate in the transfer of processes to GMP Operations and/or collaborators for use in clinical trial production
• Other duties as may be assigned

Candidate must possess:

• Degree in cell biology, biochemistry or a related discipline
• 2-5 years of biotech experience with hands on experience with cell based products (primary cells and mammalian cell culture, aseptic technique, closed system technology, and operation and maintenance of cell processing equipment)
• Strong work ethic and a proven ability to work well in a multi-disciplinary project team environment
• Must have a solid understanding of cell process and cell culture techniques for primary cells and mammalian cell culture outside of the hybridoma field
• Knowledge of cGMP cell culture processes, equipment, closed systems, cryopreservation techniques, and cell based assays, immunoassays, FACS analysis, primary cell characterization, relevant laboratory instrumentation and GTP, cGMP and ICH regulations and guidelines
• Must have excellent organizational, written communication and oral communication skills.

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.

GMP Support Technician

Job Code: GMP-Tech-SCI

We are currently seeking a GMP Support Technician to support the manufacturing areas to be used for the Company’s GMP-compliant production and testing.

Responsibilities will include:

• Prepare and clean manufacturing areas, equipment, lab ware and materials to be used for GMP-compliant production and testing of cell-based therapeutic products
• Perform and document all activities in compliance with cGMP’s
• Sanitize all materials and equipment entering the manufacturing areas
• Maintain appropriate stock of sanitized materials for production activities
• Clean manufacturing areas and equipment to be used for production activities
• Receive, store, and issue materials used in production and testing
• Monitor and clean rooms and equipment as scheduled (daily, weekly, quarterly, annually)
• Other duties as assigned, including routine environmental monitoring of manufacturing areas

Candidate must possess:

• High school diploma with 1-2 years experience working in a pharmaceutical or biotechnology environment
• GMP experience preferred
• AA in biological sciences or Biotechnology Certificate a plus
• Ability to work is a fast paced dynamic environment
• Strong attention to details and compliance with cGMP documentation requirements
• Good communication skills, both oral and written
• Must be able to work with QA, QC, and other cross-functional team members
• Basic computer skills required
• Must be willing to be flexible in daily job responsibilities and work schedule
• Able to travel between company and contract manufacturing site
• Must be able to comply with clean room gowning requirements and maintain qualification

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