Temporary Scientist, Formulation Fill/Finish

Sangamo Therapeutics, Inc.; Brisbane (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

Sangamo Therapeutics is seeking a Temporary Scientist for Formulation Fill/Finish to lead drug product formulation and process development. The role involves collaborating across teams to drive product excellence and requires a Ph.D. or equivalent experience in a relevant field. This temporary position is onsite in Brisbane, CA, focusing on developing best-in-class viral vector and cell therapy products.

Qualifications

• 6+ years of product development experience in industry.
• Experience with biologics formulation development is highly desirable.
• Knowledge of cGMP and ICH requirements.

Responsibilities

• Lead formulation and DP process development for clinical candidates.
• Design and execute process characterization studies.
• Author and review technical reports for regulatory submissions.

Skills

Analytical methods

Communication

Interpersonal skills

Project management

Education

Ph.D. in biochemistry, pharmaceutical sciences, or related discipline

BS/MS with 8+ years of experience

Job description

Temporary Scientist, Formulation Fill/Finish

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Sangamo Therapeutics, Inc. provided pay range

This range is provided by Sangamo Therapeutics, Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$71.00/hr - $102.00/hr

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Position: Temporary Scientist, Formulation Fill/Finish

Manager: Vice President, Technical Development

Department: Formulation & Fill/Finish, Technical Operations

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 and cell therapy products. The successful candidate will be responsible for the formulation and DP process development of clinical candidates, design and execute process characterization/validation studies, lead technical process transfer to internal and external manufacturing sites in support of clinical development and commercialization of Sangamo’s internal and partnered programs. The scientist will be responsible for authoring and reviewing technical reports and sections for regulatory submissions. The scientist 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 work independently, leading projects and self-managing work packages with appropriate communication and escalation. This is a temporary assignment which will be onsite in our Brisbane, CA facility. We are only considering candidates local to the San Francisco Bay Area.

Essential Functions

• Lead and/or participate in development activities to support clinical (Phase I-III) formulation and DP process development, BLA licensure and commercial launch
• Lead and/or participate in CMC/project teams for functional representation as well as support teams’ objectives and project deliverables.
• Plan, design and execute univariate/multivariate studies to develop robust and manufacturable formulations to support Tox, phase I/III formulation and DP process development.
• Perform analytical testing with chromatographic and biophysical methods (e.g. SEC-MALS, DLS, spectroscopy etc.) to support product and process characterization.
• Process data, compile results, report and communicate study findings at functional and CMC team level.
• Author and review technical protocols and reports to document study findings in support of Investigational New Drug (IND), BLA, as well as global marketing application submissions.
• 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.
• Excellent communication and interpersonal skills, and proven ability to work effectively in a matrix organization to meet team objectives
  
  

Education, Experience And Skills Requirements

• Ph.D. in biochemistry, pharmaceutical sciences, biochemical engineering, or related discipline and of 6+ years of product development experience in industry or BS/MS with 8+ years of experience.
• Experience with biologics formulation development, DP process design and manufacturing Fill/Finish is highly desirable.
• Sound understanding of analytical methods (qPCR/ddPCR, UV-Vis, H/UPLC, capillary electrophoresis and biophysical techniques (e.g. DLS, CD, FTIR, DSC, AUC, Fluorescence, particle analysis, etc.) for formulation characterization.
• Experience in QbD methodologies and statistical analysis using JMP or Minitab.
• Good knowledge of HA guidance as well as cGMP and ICH requirements.
• AAV gene therapy, Cell Therapy & Gene Editing experience is desirable.
• Team player, with good interpersonal and organizational skills.
• Self-starter, solution oriented with collaborative mindset and strong executive presence with strategic and analytical mindset
  
  

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 [e-mail]. We will reach out to you directly if there is a business need for your services.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Temporary

Job function

• Job function

  Research, Analyst, and Information Technology

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