Genentech Technical Development Scientist, Analytical Development (Microbiological) in South San Francisco, California
Technical Development Scientist, Analytical Development (Microbiological)
South San Francisco
California, United States of America
Job ID: 202008-122435
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The Technical Development Scientist Analytical Development (Microbiological) is part of 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 Scientist will ensure relevant analytical and microbiological methods are developed, validated and implemented from early development through product licensure. Responsibilities will include characterization, method development and qualification, supporting process development, release and stability testing of novel drug substance and drug products. The Technical Development Scientist will report to the Analytical Lead and interact closely with the dedicated, cross-functional iNeST team members in South San Francisco, Hillsboro, and Basel, as well as across the Global Roche organization and with our external collaborators in Germany.
Development and qualification of analytical and microbiological release, stability and characterization assays needed to support process development, characterization, 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 and microbiological method validation and transfers to QC and manufacturing site(s) including corporate partners
Establish and build analytical and microbiological method development capabilities for current and future programs
Author technical reports in support of analytical and microbiological 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
PhD, Bachelor or Master degree in chemistry, biochemistry, chemical engineering or a related discipline and 5 to 8 years relevant experience in the pharmaceutical industry within analytical development.
Candidates must have a strong background in PCR, LC-MS or GC-MS, and/or other analytical and microbiological techniques.
In depth knowledge of microbial physiology, pharmaceutical microbiology, cell biology and cellular engineering
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
Demonstrated 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
Who We Are
Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis.
Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.
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Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.
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