Senior Specialist, Quality Control - Microbiology
Manager: Manager, Quality Control, Microbiology
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.
The Senior Specialist, Quality Control - Microbiology will perform QC activities associated with the GMP production and testing of the Company’s products. Such products include recombinant Adeno-associated Viral Vectors (rAAV), gene-modified T cells and hematopoietic stem cells. The QC Specialist will be responsible for microbiology testing, method qualification and verification activities.
- Serves as Subject Matter Expert for internal or external matters. Participates in inspection readiness activities and significantly involved in inspections by regulatory agencies
- Responsible for authoring QC Micro related protocols, and reports for the purposes of method qualification/verification
- Assist with preparing SOPs, results summaries, assay/equipment qualification and validation protocols, reports and other documentation
- Ensures all issues/documentation associated with each process in assigned area have been resolved and approved are compliant with cGMPs and SOPs and current manufacturing regulations and site procedures
- Maintain QC laboratory equipment, systems and inventory for GMP compliant testing
- Keep accurate and complete records per cGMP and compile trending reports as required
- Other duties as assigned
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- Minimum BS in Biology with a focus in Microbiology, Molecular, Cellular Biology or Virology. Master’s degree preferred.
- 5+ years’ of quality control microbiology experience in the pharmaceutical industry providing guidance to Manufacturing Operations, QA, and other cGMP areas is required.
- Demonstrated in-depth experience of performing QC functions associated with the GMP production and testing of biologic products in an industry setting
- Direct experience in microbiological method qualifications in accordance with USP/EP/JP guidelines
- Knowledge of and the ability to implement CFR, USP, and ICH requirements.
- Understand regulatory guidelines for microbiological test methods and translate guidelines into effective experimental designs.
- Understanding of Microbiological assays such as Bioburden, Endotoxin (LAL), Growth Promotion, Sterility, Mycoplasma.
- Experience tracking and trending Microbiological data, with the ability to identify and report aberrant results to manager and conduct or assist in laboratory investigations.
- Strong Independent judgement, decision-making capability and ability to think conceptually and understand impact of decisions critical
- Capability to establish good relationships with others who have different values, cultural styles and perspectives
- Sound understanding and demonstrated application of statistical methods/tools
- Excellent interpersonal, written and oral communication skills
- Ability to operate in a fast-paced, multi-disciplinary industrial environment
- Physical requirements: work on your feet for several hours in a clean room environment
- Travel requirements: Less than 10%
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.
If you wish to be considered for the presentation of candidates, please contact us through Recruiting@sangamo.com. Attach your contact information, your area of specialty, and any marketing information you wish to provide. Someone form the Talent Acquisition Department will contact you directly if there is a business need for your services.