Specialist, QC - Analytical Immunoassay
Company: Sangamo Therapeutics, Inc.
Posted on: May 15, 2022
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 top talent to join our mission. Let's
build a better future together. JOB SUMMARY: 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
- 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. OTHER QUALIFICATIONS:
- 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
- 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. COVID-19 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.
Keywords: Sangamo Therapeutics, Inc., San Francisco , Specialist, QC - Analytical Immunoassay, Other , Brisbane, California
Didn't find what you're looking for? Search again!