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Technical Development Senior Research Associate/Associate Scientist, Analytical Development (Individualized Therapies)

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Company :
Roche

Location :
South San Francisco, California

Expiry Date :
Tue, 15 Jun 2021 23:59:59 GMT

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Description :
Technical Development Senior Research Associate/Associate Scientist, Analytical Development (Individualized Therapies) The Technical Development Senior Research Associate/Associate Scientist role is part of the Analytical Development group within the Individualized NeoAntigen-Specific Immunotherapy team in the Pharma Technical organization (PT-iNeST) based in South San Francisco. iNeST is an RNA-based individualized cancer immunotherapy. In this role, the Technical Development Senior Research Associate/Associate Scientist will ensure relevant analytical methods are developed, validated and implemented from early development through product licensure. Responsibilities will include product characterization, method development and qualification, supporting process development, as well as release and stability testing of novel drug substance and drug products. The Technical Development Senior Research Associate/Associate Scientist will interact closely with the dedicated, cross-functional iNeST team members in South San Francisco and Hillsboro, as well as across the Global Roche organization and with external collaborators. Main responsibilities Development and qualification of analytical release, stability, and characterization assays needed to support process development as well as clinical and commercial manufacturing Design, execution, and analysis of experiments to support process development activities within the PTD labs. Presentation of results to cross-functional teams and corporate partners Support analytical method validation and transfers to QC and manufacturing site(s) including corporate partners Establish and build analytical method development capabilities for current and future iNeST programs Author technical reports in support of analytical development and process development activities Collaborate and/or author sections of documents to be reviewed by health authorities (e.g. INDa, IMPDa, BLA) Who You Are Bachelor or Master degree in chemistry, biochemistry, chemical engineering or a related discipline and 4 to 7 years relevant experience in the pharmaceutical industry within analytical development. (Senior Research Associate) PhD in chemistry, biochemistry, chemical engineering or a related discipline and 1 to 3 years relevant experience in the pharmaceutical industry within analytical development. (Associate Scientist) Candidate must have a strong background in standard analytical techniques (i.e. CE, HPLC, Mass Spec, etc.) while experience/background in nucleic acid techniques (i.e. PCR, sequencing, etc.) is a strong plus. In depth knowledge of GMP biotechnology manufacturing. Experience with ATMPs or in the field of RNA therapeutic products is a strong plus. High flexibility and strong problem solving skills to meet business objectives. A ‘can-do’ attitude, with the ability to deal with ambiguity and to think out of the box and challenge the status quo Ability to independently manage complex situations as well as to coordinate multiple tasks and manage priorities Strong verbal and written communication skills including the ability to present scientific results clearly and concisely A strong desire to work in a collaborative, multi-disciplinary environment; demonstrated ability to effectively interact with global cross-functional project teams Customer-focused, motivated, detail-oriented, with excellent organizational skills German language proficiencies (verbal and written) a plus #LI-AD1 #PTCareers Job Overview Organisation Roche Industry Pharmaceuticals Location South San Francisco, California Country United States Expires on 13/06/2021