South San Francisco, California
This process development engineer role is part of the Pharma Technical Development (PTD) Individualized team in South San Francisco. More specifically, you will be part of a dedicated cross-functional team working on the development and manufacture of nucleic-acid based Individualized Neoantigen Specific Immunotherapies or iNeSTs (previously referred to as personalized cancer vaccines) iNeSTs are cancer vaccines targeting neoantigens manufactured on a per-patient basis. In this role, you will support early- and late-stage RNA and DNA manufacturing process development, with an emphasis on DNA and RNA production including cell culture and purification. Specifically, you will support process development and characterization, equipment evaluation, process transfers and clinical manufacturing.
Job Description Summary
Contribute to process development activities to support early- and late-stage clinical manufacturing and process transfer to new manufacturing sites. Identify and solve technical issues, perform process development experiments and evaluate and implement new technology/instrumentation based on scientific literature and industry trends. Act as a technical subject-matter representative on cross-functional teams. Play a role in departmental or other special projects. May assist in on-boarding and training new members.
In this challenging role, you will:
Design, execute and analyze experiments to support development and optimization of purification processes for RNA and DNA, including, but not limited to harvest, chromatography, and filtration operations
Collaborate with PTD Individualized team members and external partners to develop and implement improvements to clinical manufacturing processes and to develop late-stage/commercial manufacturing processes.
Support the design and evaluation of drug substance equipment.
Be responsible for authoring technical reports, work instructions, and data visualization techniques to support process development and evaluation
Support the process transfer of drug substance manufacturing unit operations to commercial manufacturing site(s).
B.S. in bioscience or bioengineering disciplines with at least 4-7 years of cross-functional process and analytical development experience
Experience with lab-based DNA and RNA techniques, especially in the area of nucleic acid production including cell culture and purification
Proficiency in laboratory techniques, including FPLC, HPLC, filtration systems; familiarity with CE, mass spectrometry, and other spectroscopic methods is a plus
Excellent influencing-without-authority and negotiating skills when interacting with stakeholders; strong collaboration and teamwork skills
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
Autonomous with ability to manage complex situations successfully as well as to coordinate multiple tasks and manage priorities
This position requires up to 10% domestic and international travel.
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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