Senior Specialist, Quality Control, Raw Materials
Manager: Senior Manager, Quality Control, Raw Materials
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.
Sangamo Therapeutics' is seeking a highly motivated QC Specialist with hands-on experience in raw material qualification testing. The Specialist will perform QC activities associated with the GMP production and testing of the Company’s raw materials. Such products include recombinant Adeno-associated Viral Vectors (rAAV), gene-modified T cells and hematopoietic stem cells. The QC Associate Specialist will be responsible for SOPs initiation and revision, method qualification and verification activities for raw materials.
- Serves as Subject Matter Expert for internal or external matters on raw material qualification. Participates in inspection readiness activities and involved in inspections by regulatory agencies.
- Understanding USP/EP requirements for raw materials testing including test requirement, specification. and methods.
- Responsible for authoring QC raw material SOPs including SOPs initiation, verification/qualification based on USP/EP and ICH requirements.
- Responsible for authoring QC raw material related protocols, and reports for the purposes of method qualification/verification based on USP/EP requirements.
- Assist with preparing SOPs, results summaries, equipment qualification/validation protocols, reports and other documentation.
- Responsible for raw material qualification test using effective SOPs, and maintain QC laboratory equipment, systems and inventory for GMP compliant testing.
- Assist with deviation initiation, OOS investigation and CAPA execution related to raw material qualification.
- Keep accurate and complete records per cGMP and compile trending reports as required.
- Other duties as assigned.
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
The ideal candidate for this position will have demonstrated in-depth experience of performing QC functions associated with the GMP production and testing of raw materials in an industry setting.
Candidate must possess:
- Minimum BS in chemistry, biochemistry or Microbiology. Master’s degree preferred.
- Must have at least 1-2 years quality control working experience in the bio/pharmaceutical industry focusing on wet chemistry and instrumentation.
- Have direct experience in raw material method development, qualifications/verification in accordance with USP/EP guidelines.
- Knowledge of and the ability to implement CFR, USP, and ICH requirements.
- Understand both FDA and EU requirements on raw material qualifications.
- Must be able to troubleshoot and produce creative solutions.
- Must have ability to work both independently and in a team-oriented environment with minimal supervision.
- Must be able to identify and report aberrant results to manager and conduct or assist in laboratory investigations.
- Must have hands-on experience on FTIR, UV/Vis, Conductivity Meter and pH Meter. Experience on HPLC is a plus.
- Capability to establish good relationships with others who have different values, cultural styles and perspectives.
- Excellent interpersonal, written and oral communication skills.
- Ability to operate in a fast-paced, multi-disciplinary industrial environment.
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.