Specialist, QC – Analytical Immunoassay
Manager: Associate Director, Quality Control
Department: Technical Operations
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 a talented and highly motivated Specialist to join our QC Analytical-Immunoassay team. The Specialist will be tasked to perform GMP QC testing on manufacturing intermediates and released drug products in support of our internal and external cell and gene therapy manufacturing operations. Products to be tested include, but are not limited to, recombinant viral vectors (AAV and lentivirus), ex-vivo gene-modified T cells, and gene editing mRNAs. The QC Specialist will be responsible for routine testing, assay transfer and validation (qualification/verification/validation), assay trouble shooting, QC documentation preparation and revision (SOPS/Protocols/Reports), and laboratory setup and maintenance.
- Deals with internal and external matters related to QC analytical testing of intermediates and final drug products. Analytical techniques include, but are not limited to, single and multi-color flow cytometry assays, immunoassays (immunoblotting and ELISAs), and gel-based assays (SDS-PAGE and CE-SDS).
- Responsible for routine QC testing, data review, and preparation of summary reports.
- Participates in inspection readiness activities. May represent QC during audits by regulatory agencies.
- Understands USP/EP requirements for product release testing and analytical method validation and transfer.
- Supports authoring, review, and approval of QC Analytical SOPs, Protocols, and Reports.
- Assist with equipment qualification and/or validation activities: drafting and executing IOQ protocols, drafting and reviewing reports and other documentation.
- Responsible for conducting and/or assisting with laboratory investigations: deviations, OOS/OOT, aberrant/unexpected results, and invalid results.
- Responsible for conducting and/or assisting with the identification, initiation, and closure of quality events (Deviations and CAPAs) related to analytical testing.
- Responsible for keeping accurate and complete records (test records and laboratory notebooks) per cGMPs.
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
The ideal candidate for this position will have demonstrable in-depth knowledge and understanding of QC functions associated with the testing of ATMP manufacturing intermediates and final drug products in an industry setting
- Possess a BS degree in the Life Sciences (Molecular and Cellular Biology, Biochemistry, or a related field). Course work in immunology, virology and cell biology is a plus.
- 0-3 years of quality control experience in a QC analytical laboratory setting. Strong experience working in ATMP (Advanced Therapeutic Medicinal Products Field - Cell and Gene Therapy).
- Have extensive hands-on experience with single and multi-color flow cytometry assays to include method development and optimization, sample preparation and staining, compensation, cytometer calibration and standardization, as well as gating and data analysis.
- Have direct experience executing immunoassays in a cGMP QC environment. i.e. ELISAs and quantitative Western blots.
- Have experience and knowledge of analytical method development, verification, qualification/validation, and transfer in accordance with USP/EP guidelines.
- Regularly apply 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.
- Possess excellent oral communication skills.
- Possess excellent scientific writing skills (a scientific publication record is a plus).
- Possess strong interpersonal skills with the capability to establish collaborative working relationships within QC, and with members of the Analytical Method Development, Manufacturing, and QA teams.
- Ability and desire to operate in a fast-paced, multi-disciplinary industrial environment.
- The successful candidate must embrace a flexible work schedule. This is a first shift M-F position, but occasional evening or weekend hours may be required.
Sangamo is an equal opportunity employer
The above reflects management’s definition of essential functions for this position but does not restrict the tasks that may be assigned. The above duties are representative only; management may assign or reassign duties and responsibilities to this position at any time.
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, you will have an opportunity to request a reasonable accommodation consistent with applicable laws.
Note to External Recruiters: Please understand that we do not accept unsolicited resumes from any source other than from the candidates themselves. Any agency or independent recruiter must have a signed copy of our agency agreement before presenting candidates. Submission of unsolicited resumes without our signed agreement will not create any implied obligation on our part.