Manager: Associate Director, Quality Control Analytical
Department: Technical Operations – Quality Control
Sangamo Therapeutics is a genomic medicines company that is building value by developing cutting-edge therapeutics utilizing distinct but complementary genome editing and gene regulating platforms. At Sangamo, we are passionate about developing genomic medicines that will transform the lives of patients with serious, life-limiting diseases by aggressively developing and delivering our innovative, high value genomic medicines pipeline. Sangamo takes pride in being the first company to edit endogenous human genes, the first company to treat patients with gene edited T cells, and the first company to treat patients using targeted in-vivo genome editing therapeutics. Sangamo is a company where individuals can flourish, grow, and develop their expertise. We are seeking top talent to join our team. Let’s build a better future together.
We are seeking a talented and highly motivated Senior Specialist to join our QC -Immunoassay team. The Senior 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 ex-vivo gene-edited cell therapies (for the treatment of sickle cell disease) and recombinant viral vectors (AAV and lentivirus). The QC Senior Specialist will be responsible for routine testing, assay transfer and validation (qualification/verification/validation), assay trouble shooting, QC document preparation and revision (SOPs/Protocols/Reports), and laboratory setup and maintenance.
- Serves as Subject Matter Expert for 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.
- Authors, reviews, and approves 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.
- 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 demonstratable in-depth knowledge and understanding of QC functions associated with the testing of ATMP manufacturing intermediates and final drug products in an industry setting.
The successful candidate must:
- Possess, at minimum, 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.
- Have 5-8 years of quality control experience in a QC analytical laboratory setting with at least. 5 years working with ATMPs (Advanced Therapeutic Medicinal Products - 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. Experience analyzing autologous and allogenic cell therapy products is a must.
- 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.
- The successful candidate will possess excellent oral communication skills.
- The successful candidate will possess excellent scientific writing skills (a scientific publication record is a plus).
- The successful candidate should 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.
- The successful candidate will have the ability to operate in a fast-paced, multi-disciplinary industrial environment.
- The successful candidate must have 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.