Senior Specialist, Quality Control Operations (Stability & Reference Standards)

Manager: Associate Director, External 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.

JOB SUMMARY:   

We are seeking a talented and highly motivated individual to join our QC Operations team to develop and maintain stability and reference standard programs in support of our internal and external cell and gene therapy manufacturing operations. Products to be supported include, but are not limited to, recombinant viral vectors (AAV and lentivirus), ex-vivo gene-modified T cells, and gene editing mRNAs. You will be responsible for coordinating the routine testing of stability samples, trending stability data, establishing shelf life for DS and DP, investigating stability failures, qualifying primary and working reference standards, and trending reference standard performance and stability.

ESSENTIAL FUNCTIONS: 

• Work with QC senior management to design, implement, and oversee a compliant, inspection ready QC stability program. Specific duties will require:
  • The development of stability protocols to evaluate long-term, accelerated, and stressed storage conditions for each of Sangamo’s platform products.
  • Overseeing the execution of all stability protocols managed via our CDMO partners – ensure the timely receipt and review of all stability data. Ensure externally generated stability data is trended in a timely manner.
  • Managing the execution of all in-house stability protocols – coordinate with QC testing labs to ensure all testing is executed within the acceptable stability timepoint windows.
• Work with the Formulation Development group to design and support in-use stability programs.
• Work with Sangamo Quality Assurance to establish/extend product shelf-life.
• Trend all stability data and work with QC senior management to resolve all stability failures. Lead investigation of stability OOS and OOT results.
• Assist QC management during all inspections and regulatory audits with emphasis on stability data and shelf-life determination/extension.
• Draft and review QC-stability documents (SOPs, Protocols, Reports etc).
• Work with regulatory to provide stability data in support of regulatory filings and annual reports.
• Develop reference standard program for each of Sangamo’s platform products.
• Work with Analytical Development groups to design characterization and stability programs for in-house generated reference materials for early phase studies.
• Develop, characterize, and implement a two-tiered reference standard program for each late phase-commercial product.

EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:

The ideal candidate for this position will have demonstrable in-depth knowledge and understanding of the development and implementation of Stability and Reference material programs.

• BS in Biology, Chemistry, or related field.
• 5+ years of Quality Control-stability experience in the biopharma or medical device fields.  An understanding of the QC testing required for gene and cell therapy products is highly desirable.
• Understand current GMPs with a familiarity of ICH, FDA, USP, and EMA (Ph Eur) guidelines as applicable to stability testing and the establishment/extension of product shelf-life.
• Experience with statistical analysis as related to interpretation of stability data.  

OTHER QUALIFICATIONS:

• Able to operate in a fast-paced start-up environment handling multiple product lines and manufacturing operations.
• Able to work in a laboratory environment wearing appropriate PPE.
• Excellent communication skills, both written and verbal
• Detail oriented.
• A self-starter, able to complete task without direct management oversight.
• Possess strong interpersonal - team player – skills.
• Have flexibility in their work schedule: early, late and 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.