QC Specialist, NAT (CONTRACT)

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:   

Sangamo Therapeutics is seeking a talented and highly motivated QC Specialist (Contract) to join our QC Analytical - NAT group. The QC Specialist (Contract) 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 Senior Specialist will be responsible for routine testing, assay transfer and validation assay trouble shooting, QC document preparation and revision (SOPs/Protocols/Reports), laboratory investigations, and laboratory setup and maintenance.

ESSENTIAL FUNCTIONS:

• 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 Nucleic Acids Testing (NAT): PCR assays and DNA/RNA sequencing assays.
• 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.
• 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.
   

EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:

• 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 2+ years of quality control experience in a QC analytical laboratory setting with demonstrable in-depth knowledge and understanding of QC functions associated with the testing of ATMP (Advanced Therapeutic Medicinal Products Field - Cell and Gene Therapy) manufacturing intermediates and final drug products in an industry setting.
• Have extensive hands-on experience with NAT: DNA extraction (manual and automated), PCR, and DNA/RNA sequencing (NGS, MiSeq, CE-Sanger etc.). Have direct/indirect experience and knowledge of classical virology techniques: i.e., plaque assays, tissue culture infectious dose assays (TCID50).
• Have experience and proficiency with cell culture and aseptic handling of test articles.
• 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:

• 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 and maintain 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
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 than from the candidates themselves.