Senior Scientist, Upstream Process Development
Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company based in South San Francisco, California that is dedicated to defeating neurodegenerative diseases through rigorous therapeutic discovery and development. Denali is founded on the collaboration of leading scientists, industry experts, and investors who share the vision that scientific discovery energetically applied to translational medicine is the key to delivering effective therapies to patients.
We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.
We are seeking to hire a highly motivated and collaborative Senior Scientist/Principal Scientist to join our Bioprocess Development team, focused on cell culture process development & manufacturing. The successful candidate will play an active role in supporting upstream cell culture activities for clinical stage manufacturing for complex large molecule biotherapeutics
- Serve as an upstream subject matter expert for experimental, tech transfer, and manufacturing support activities for clinical stage CMC programs
- Provide technical support for early-stage process development and late-stage process characterization and validation activities
- Author and review relevant CMC-related sections of regulatory filings and responses to health authority requests
- Work collaboratively with peers in downstream process development, analytical development, CMC management, manufacturing, QA, QC, regulatory, and contract manufacturers (CMOs) to achieve corporate objectives.
- Provide guidance on and help draft control strategies to enable accelerated timelines
- Keep up to date with external patents and literature, pursue external publications and presentations
- Provide mentorship to junior staff
- PhD in biology, biochemistry, chemical engineering or related scientific discipline with 6+ years of cell culture development experience in the biotech/biopharma industry; or BS/MS with 10+ years of experience.
- Strong knowledge of the scale-up/scale-down principles of cell culture processes including a thorough understanding of micro, bench-scale and pilot scale bioreactor operations
- Proven track record of representing bioprocess functions in cross-functional teams and working effectively with CMOs in leading scale-up and tech transfer activities
- Ability to work in a matrixed team environment and collaborate with both internal and external partners including vendors
- Demonstrated ability for taking initiative, creativity, and innovation in problem solving
- Demonstrated competence with design of experiments, statistical tools for analysis and interpretation of data, and electronic data management systems
- Experience with instruments routinely used in cell culture such as Vi-Cell, Nova Flex2, Octet and lab-scale bioreactors
- Experience working with novel large molecule formats such as bispecific antibodies and Fusion proteins/enzymes is a plus
- Working knowledge of protein purification, protein characterization and analytics is a plus
- Demonstrated technical writing, critical thinking, scientific problem-solving and communication skills
Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.
Salary Range: $142,000.00 to $183,000.00. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careers
*This compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.
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