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Senior Specialist, Quality Control-Stability Management/Shelf Life Extension (Cell/Gene Therapy)

Employer
Sangamo Therapeutics, Inc.
Location
Brisbane, CA
Salary
$109,000 - $125,000 per year
Start date
Mar 10, 2023

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Job Details

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. 

 We are seeking top talent to join our mission. Let's build a better future together. 
JOB SUMMARY:    

Sangamo Therapeutics is seeking a Senior Specialist to oversee the Quality Control – Stability and Reference Standard programs at our Brisbane, CA manufacturing and testing facility. This position is fully, 100% on-site (hybrid and remote work are not an option with this role).    

 ESSENTIAL FUNCTIONS:  
  • Work with QC management to design, implement, and oversee a compliant, inspection ready QC Stability program. Specific duties include:
    • Developing 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 the Process, Analytical, and Formulation Development groups to design characterization and stability programs for in-house generated reference materials.
  • Work with Sangamo Analytical Method Development to assess stability indicating test methods and analytical procedures.
  • Work with Sangamo Quality Assurance to establish/extend product shelf-life.
  • Trend all stability data and work with QC management to resolve all stability failures. Lead investigation of stability OOS and OOT results.
  • Manage stability calendars for all ongoing stability programs.
  • Assist QC management during all inspections and regulatory audits with emphasis on stability data and shelf-life determination/extension.
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS: 
  • Possess a BS in Molecular Biology, Biochemistry, Virology, Immunology, or related field.
  • Have 7-10 years of Quality Control-experience with at least five years dedicated to coordinating and managing stability programs.  A thorough understanding of the QC testing required for gene and cell therapy products is required.
  • Be able to interact with laboratory personnel and management to lead laboratory investigations as applies to stability failures.
  • Understand current GMPs with a strong knowledge of ICH, FDA, USP, and EP guidelines as applicable to stability testing and product shelf-life.
  • Have proficiency with stability trend analysis and establishing shelf-life and shelf-life extensions.
  • Be proficient with JMP statistical software and regression analyse

 OTHER QUALIFICATIONS: 
  • Be able to operate in a fast-paced start-up environment handling multiple product lines and manufacturing operations. Sangamo Therapeutics has a diverse pipeline and operates multiple stability studies across all platforms simultaneously.
  • Must be detail oriented. Must be able to track stability calendars, pull dates, and testing windows for multiple products.
  • Be able to work in a laboratory environment wearing appropriate PPE.
  • Have excellent communication skills, specifically the successful candidate must be a proficient technical writer. Written communication involves protocol generation, report generation and drafting stability sections for all regulatory filings.
  • Be a self-starter, able to complete tasks without direct management oversight. The stability coordinator is an independent/individual contributor role that operates free of day-to-day oversight.
  • Possess strong interpersonal - team player – skills. Must be able to effectively interact with individuals from several unique functional groups.
  • Have flexibility in their work schedule: early, late and weekend hours may be required periodically.
  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, you will have an opportunity to request a reasonable accommodation consistent with applicable laws.    Pay Range
The anticipated salary range is for candidates who will work in our Brisbane or Point Richmond, CA offices. The final salary offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and length of experience with the job, type and length of experience within the industry, education, etc. This salary range may not apply to remote positions that work in other states.    Note to External Recruiters:  We do not accept unsolicited resumes from any source other than from the canditate themselves.  If you wish to be considered for the presentation of candidates, please email recruiting@sangamo.com. We will reach out to you directly if there is a business need for your services.   #LI-KO1 
 

Company

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. At Sangamo, we are passionate in developing genomic medicines to transform the lives of patients with serious diseases. We transform 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.

Stock Symbol: SGMO

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Company info
Website
Phone
(510) 970-6000
Location
7000 Marina Blvd
Brisbane
CA
94005
United States

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