Temporary Senior Scientist, Formulations Fill/Finish

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Company :
Sangamo Therapeutics

Location :
Brisbane, California

Expiry Date :
Sun, 28 Mar 2021 23:59:59 GMT

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Description :
Job Details TemporaryEstimated: $65,000 – $80,000 a year4 hours ago Qualifications – Laboratory experience – Cell culture – Communication skills – Organizational skills – Biotechnology – Bachelor’s degree – Doctoral degree – Master’s degree Full Job Description Manager: Senior Director, Formulations Department: Technical Operations – Cell & Gene Therapy, Formulations & Fill/Finish Location: Brisbane 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 resses 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 highly motivated individual 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 Sr. scientist will be responsible for authoring and reviewing technical reports and sections for regulatory submissions. The successful candidate will operate in a matrixed environment and collaborate successfully with colleagues within Technical Operations and cross-functionally with pre-clinical and clinical team members to drive product and process excellence. This individual will work independently, leading projects and self-managing work packages with appropriate communication and escalation. ESSENTIAL FUNCTIONS: Plan, design and execute univariate/multivariate studies to develop robust and manufacturable formulations to support Tox, phase I/III formulation and DP process development. Process data, compile results, report and communicate study findings at functional and CMC team level. Author, review functional and cross-functional process development and characterization protocols, multivariate studies, technical reports and drive timely execution with quality oversight. Develop and implement novel biochemical and biophysical methods suitable for cell and gene therapy molecular assessment and product characterization. Lead and/or participate in CMC/project teams for functional representation as well as support teams’ objectives and project deliverables. Author and review technical protocols and reports to document study findings in support of Investigational New Drug (IND), IND amendments, 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, with proven ability to work effectively in cross-functional teams to meet project milestone and timelines. EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS: BS/MS/PhD degree in biochemistry, pharmaceutical sciences, biochemical engineering, or related discipline. ~5 years of laboratory experience in biotechnology or pharmaceutical industry. Experience with biologics formulation development, DP process design and manufacturing Fill/Finish is highly desirable, however, academic experience related to cell culture, analytical chemistry, viral vectors, or gene therapy will be considered. Proficiency withing chromatographic (HPLC, UPLC, column chromatography) methods, capillary electrophoresis and biophysical techniques (UV-vis, DLS, CD, FTIR, DSC, AUC, Fluorescence, particle analysis, etc.) for formulation characterization. AAV gene therapy, Cell Therapy & Gene Editing experience is desirable. Sound understanding of statistical methods and data analysis tools (e.g. JMP). Team player, with good interpersonal and organizational skills. 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. #LI-KO1 Show full job description Quick