Scientist III, Formulation and Fill/Finish, Contractor
Sangamo BioSciences, Inc.
Expiry Date :
Fri, 16 Apr 2021 23:59:59 GMT
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Position: Scientist III, Formulation and Fill/Finish, Contractor Location: Brisbane, CA Job Id: T # of Openings: 1 Manager: Sr. Director, Formulations Department: DP Formulation and Process Development 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 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. Sangamo is a company where individuals can flourish, grow and develop their expertise. We are seeking top talent to join our team. 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 position. ESSENTIAL FUNCTIONS: – Plan, design and execute univariate/multivariate studies to develop robust and manufacturable formulations and processes for gene therapy products – Develop and implement novel biochemical and biophysical methods suitable for cell and gene therapy 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 guidance documents, SOPs, technical protocols, reports and regulatory sections 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. – Manage and coordinate resources across programs and teams to ensure timely and successful achievement of program/team goals. – 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 a minimum of 2+ years of product development experience in industry or BS/MS with 7 + years of experience. Level will be dependent upon skills and experience. – Experience with biologics formulation development, DP process design and manufacturing Fill/Finish is highly desirable – Proficiency with applying 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 – 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 – Sound understanding of statistical methods/tools for data analysis. – 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