Specialist, Quality Control - Analytical Chemistry (CONTRACT)

Location
Brisbane, CA
Posted
Apr 27, 2022
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Contract

Manager: Senior 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 Temporary Quality Control Specialist to join our QC Analytical-Chemistry team. The QC Associate will be takes 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 Associate will be responsible for routine testing, supporting assay transfers and qualifications, preparing QC documents, laboratories maintenance, and assisting with laboratory investigations.

ESSENTIAL FUNCTIONS: 

  • Routine QC testing, data review, and preparation of summary reports. Analytical testing includes, but is not limited to, pH, osmolality, TOC, appearance, extractable volume, viable cell density, and ID testing (HPLC). 
  • Participate in inspection readiness activities.
  • Understands and follows USP/EP requirements for product release testing. 
  • Reviews QC Analytical SOPs, Protocols, and Reports.
  • Assist with equipment qualification and/or validation activities: i.e., reviewing reports and other documentation.
  • Responsible for assisting with laboratory investigations: deviations, OOS/OOT, aberrant/unexpected results, and invalid results.
  • Responsible for 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 demonstratable in-depth knowledge and understanding of QC data analyses associated with the testing of ATMP manufacturing intermediates and final drug products.

  • 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.
  • Have 0-2 years of quality control experience in a QC analytical laboratory setting. Experience testing ATMP (Advanced Therapeutic Medicinal Products Field - Cell and Gene Therapy) is a plus.
  • Have hands-on experience (can be academic laboratory experience) with analytical instrumentation: HPLCs, pH meters, automated cell counters, TOC analyzers etc.  
  • 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 assist in laboratory investigations.
  • Have a willingness to learn.

OTHER QUALIFICATIONS:

  • Possess excellent oral & written communication skills.
  • Possess strong interpersonal skills with the capability to establish collaborative working relationships across QC functions, and with members of the Product Development, Manufacturing, QA, and Regulatory teams.
  • Ability to operate in a fast-paced, multi-disciplinary industrial environment.
  • Must be open to 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.