Senior Scientist, Formulation Fill/Finish

Title: Senior Scientist, Formulation & Fill/Finish

Manager: Associate Director, DP MSAT

Department: Formulation & Fill/Finish

Location: Brisbane, CA

Sangamo Therapeutics is a genomic medicine company focused on treating debilitating neurological diseases, by using our wholly owned, highly versatile zinc finger epigenetic regulation technology and capsid delivery engine. We are passionate about designing and developing genomic medicines to transform the lives of patients suffering from severe diseases with our deep scientific expertise and proprietary zinc finger genome engineering technology. At Sangamo, we are dedicated to building a robust, sustainable genomic medicine pipeline that addresses life-limiting conditions by replacing today's symptom-focused treatments with tomorrow's genomic cures. 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 highly motivated individual with drug product formulation and process development experience to contribute to the development of best-in-class viral vector genomic products. The successful candidate will be responsible for Formulation and Drug Product process development of clinical candidates. Support the design, and execution of process characterization/validation studies, as well as lead technical process transfer to internal and external manufacturing sites, in support of clinical development and commercialization of Sangamo's internal and partnered programs. They will operate in a matrixed environment and collaborate successfully with colleagues within Technical Operations, and cross-functionally with clinical, external manufacturing, supply chain, and commercial groups to drive product and process excellence. This individual will manage, supervise teams, and support program deliverables.
WE ARE ONLY CONSIDERING CANDIDATES WHO ARE CURRENTLY LOCAL TO THE SAN FRANCISCO / BAY AREA.  

ESSENTIAL FUNCTIONS: 

• Lead formulation and Drug Product deliverables to support pre-clinical, clinical/pivotal studies leading to IND, BLA/MAA and commercial launch
• Plan, design and execute univariate/multivariate formulation and DP process characterization/validation studies, and drive timely execution with quality oversight
• Perform analytical testing with chromatographic and biophysical methods (e.g. SEC-MALS, DLS, spectroscopy etc.) to support product and process characterization.
• Devise the DP process technology transfer, qualification, and validation strategy, for clinical/commercial product site transfer  
• Provide on-going fill-finish manufacturing support to Drug Product sites/CMOs: including technology transfers and impact assessments, during quality investigations to ensure product and process consistency
• Partner with internal/external manufacturing and quality for process improvement, transfers, compilation and review of batch records, master production records and technical support to resolve investigations, deviations, corrective/preventative actions
• Author and review technical protocols and reports, to document study findings in support of Investigational New Drug (IND), IND amendments, BLA/MAA and other global regulatory filings.
• Lead and/or participate in CMC/project teams for functional representation as well as support teams' objectives and project deliverables.
• Develop and implement novel biochemical and biophysical methods suitable for gene therapy molecular assessment and product characterization.
• Build, mentor, and supervise full-time employees, contractors, and consultants, to deliver organizational goals

EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:

• Ph.D. in biochemistry, pharmaceutical sciences, biochemical engineering, or related discipline and 6+years of product development experience in industry or BS/MS with 8+ years of experience
• Experience with biologics formulation development, Drug Product process design, and manufacturing Fill/Finish, is highly desirable
• Experience with AAV gene therapy process/formulation/analytical development is a plus
• Sound understanding of analytical methods for formulation characterization (e.g. qPCR/ddPCR, UV-vis, H/UPLC, capillary electrophoresis and biophysical techniques (e.g. SEC-MALS, DLS, AUC, Fluorescence, particle analysis, etc.)
• Experience in QbD methodologies and statistical analysis using JMP or Minitab.
• Good knowledge of HA guidance as well as cGMP and ICH requirements
• Experience writing, proofing, contributin to regulatory submissions, through all phases of product development.  Experience with BLA submissions is a plus.
• Self-starter, solution oriented with collaborative mindset and strong executive presence with strategic and analytical abilities
• Excellent communication, interpersonal skills, and proven ability to work effectively in a matrix organization to meet team objectives

We encourage you to apply even if you don't meet all the qualifications. We believe in the value of diverse perspectives and backgrounds, and we welcome candidates who are eager to learn and contribute to our mission.

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.

Pay Range

The anticipated salary range is for candidates who will work in our San Francisco Bay Area work locations. 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 candidates themselves. If you wish to be considered for the presentation of candidates, please email We will reach out to you directly if there is a business need for your services.

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