QC Specialist, Analytical Chemistry
Manager: Vice President, Quality Control
Department: Technical Operations – Quality Control
Location: Brisbane, CA
Sangamo Therapeutics is a genomic medicine company building value with cutting-edge work across four distinct but complementary technology platforms – gene therapy, cell therapy, in vivo genome editing, and in vivo genome regulation. Using its deep scientific expertise and proprietary zinc finger genome engineering technology, Sangamo is working to create genomic cures for patients suffering from severe genetic diseases for which today’s medicines can only treat symptoms. At Sangamo, we are passionate about transforming lives by building a robust, sustainable, differentiated, innovative, and high value genomic medicine pipeline that addresses patients with life-limiting conditions. Sangamo takes pride in being the first to edit endogenous human genes, first to treat patients with gene edited T cells, and first to treat patients with in vivo genome editing. Our top priority is to meet the needs of patients with commitment and compassion. Along with our commitment to science and to our patients, we also endeavor to create an inclusive environment that promotes and values diversity. Sangamo is a company where individuals can flourish, grow and develop their expertise.
We are seeking top talent to join our mission. Let’s build a better future together.
We are seeking a highly motivated QC Specialist with hands-on experience in the intermediate and final product analytical testing. The Specialist will perform QC activities associated with the cGMP production and release testing of the Company’s products. Such products include recombinant Adeno-associated Viral Vectors (rAAV), gene-modified T cells and hematopoietic stem cells. The QC Specialist will be responsible for routine in-house testing and assay trouble-shooting, QC SOPs initiation and revision, laboratory setup and maintenance, analytical method validation and transfer activities.
- Serves as Subject Matter Expert for internal or external matters on QC analytical testing of intermediates and final products. The testing assays are such as but not limited to: PCR, SDS-PAGE, ELISA, Wet Chemistry, Chromatography, etc.
- Participates in inspection readiness activities and may represent QC during audits by regulatory agencies.
- Understanding USP/EP requirements for product release testing and analytical method validation and transfer. May lead in authoring and execution of method validation/transfer protocol and report.
- Responsible for authoring QC Analytical lab SOPs including initiation, revision, and lab verification/qualification based on USP/EP and ICH requirements.
- Responsible for routine QC testing and data review, preparation of result summary, assist with equipment qualification/validation protocols, reports and other documentation.
- Responsible to conduct or assist with deviation initiation, OOS/OOT lab investigation, and CAPA execution related to analytical testing.
- Keeps accurate and complete records per cGMP and compile trending reports as required.
- Provides analytical assay training and lab work coordination to junior level QC associates.
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- The ideal candidate for this position will have demonstrated in-depth knowledge and understanding of performing QC functions associated with the GMP production and testing of intermediates and final products in an industry setting.
- Candidate must possess:
- At minimum a BS degree in life science (e.g., chemistry or biochemistry) is required. Master’s degree is preferred.
- Must have 2-5 years of quality control working experience in analytical lab settings in the pharmaceutical and biologics industry. Level will be dependent upon skills and experience.
- Must have hands-on experience with analytical instrumentation such as pH meter, Osmometer, UV spectrophotometer, HPLC, etc.
- Have direct/indirect experience and knowledge in analytical method development, qualifications/verification, and transfer in accordance with USP/EP guidelines.
- Regularly applies theories and principles from one's technical / professional discipline to independently address a variety of problems of moderate to difficult scope
- Must have ability to work both independently and in a team-oriented environment with minimal supervision.
- Must be able to identify and report OOS/OOT/aberrant lab results to manager and conduct or assist in laboratory investigations.
- Capability to establish and demonstrate collaborative working relationships with internal QC, Analytical Method Development, Manufacturing, and QA colleagues.
- May interact with external customers based on request.
- Excellent interpersonal, written and oral communication skills.
- Ability to operate in a fast-paced, multi-disciplinary industrial environment
Sangamo is an equal opportunity employer
Sangamo is committed to fostering belonging for all employees and embraces diversity, equity, and inclusion in recruiting and hiring. All qualified applicants for employment are encouraged to apply and will be considered without regard to an individual’s race, color, sex, gender identity, gender expression, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws
Commitment to Safety
Sangamo requires all U.S. workers to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Sangamo, and it applies regardless of location or classification of role. If you are unable to receive the vaccine & booster, you will have an opportunity to request a reasonable accommodation consistent with applicable laws.
Note to External Recruiters: We do not accept unsolicited resumes from any source other that from the candidates themselves.