Associate Director, Analytical Development (Testing Group)

Location
Brisbane, CA
Posted
Apr 28, 2022
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Manager: Vice President, Analytical Development
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:   

The Associate Director of the Analytical Testing Group Core (ATGC) will manage a function within the Technical Development department dedicated to rapid, high throughput analytical testing needs of Process Development, Formulation Development, Vector Core and R&D departments. These analytical tests support the development of Sangamo’s cell and gene therapy projects. Ideal candidate will be experienced managing an analytical lab and dedicate a portion of their time to hands-on testing.  They will manage junior staff performing development phase and cGMP compliant analytical methods in support of department and corporate goals. They will act as the first line of inquiry for staff with respect to method trouble shooting, diagnosis of instrument issues, proper result interpretation and reporting.

The successful candidate will be responsible for leading all aspects of the Analytical Testing Group Core including method / instrument troubleshooting, generation of monthly testing metrics reports, developing robust sample management and reporting standards and managing all laboratory supply needs of the Analytical Development department. The candidate may participate cross-functional project teams, representing AD function as well as be involved in technology and/or method transfer to in-house QC department as well as external contract manufacturing organization (CMO), contract testing organizations (CTO).

ESSENTIAL FUNCTIONS: 

  • Manage a team of Analytical Development Associates to perform all analytical testing to support a wide range of departments within Sangamo’s development and R&D departments.
  • Experience with establishing laboratory control systems for sample management, data reporting standards, instrument use & employee resource scheduling, laboratory chemical and critical reagent inventory management and other related laboratory administrative functions.
  • Familiarity with and/or ability to quickly learn and teach modern analytical techniques for cell and gene therapy products such as flow cytometry, cell-based assays/immunoassay, next generation sequencing, TCID-50, qPCR, ddPCR, HPLC, capillary electrophoresis.
  • Improve and maintain an in-house ELN/LIMS function to ensure timely management of samples and results to submitting departments, including sample location and status tracking.  Write work instructions and teach all users how to submit, locate, status check and obtain results for all samples submitted.
  • Drafting and reviewing of SOPs, development report, test records and protocols to facilitate transferring methods and training staff of the internal QC department or CTOs
  • Assist in the preparation of CMC regulatory submissions
  • Other activities as may be assigned

EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:

The ideal candidate for this position will have demonstrated in-depth experience of modern biotechnology laboratory and implementation of analytical methods for the characterization, release testing and stability testing of biologic products in an industry setting.

  • BS or MS and 8+ years of experience managing a modern analytical biotechnology laboratory with a focus on analytical development.
  • Experience with implementing a ELN/LIMS systems required.  Experience with Benchling ELN a plus.
  • Experience with HPLC, Capillary Electrophoresis, ELISAs and other contemporary analytical techniques is required.  Experience with qPCR, ddPCR, TCID-50, NGS, flow cytometry and other cell, gene editing and therapy techniques is a plus.
  • Drug development experience using AAV gene transfer, CAR-T platform is preferred
  • A strong commitment to experimental work is essential, as well as the ability to independently identify and solve complex problems to advance projects through the development process
  • Demonstrated expertise in the independent design and execution of analytical development projects, DOE and statistics for data analysis
  • Strong verbal and writing skills including data documentation, project presentation, drafting technical reports, and communication of progress to manager

OTHER REQUIREMENTS:

  • Sound understanding and demonstrated application of statistical methods/tools
  • Knowledge and good understanding of FDA, EMA, cGMP, WHO and ICH regulatory requirements
  • Excellent interpersonal skills, outstanding organizational skills
  • Excellent written and oral communication skills
  • Strong analytical, organizational and communication skills
 

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.