Principal Scientist, Oligonucleotide Development and Manufacturing
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.
Denali is seeking an experienced process chemist who will play a pivotal role in the design, optimization, and scale-up of synthetic processes to produce oligonucleotides, supporting Denali’s Oligonucleotide Transport Vehicle (OTV) platform. The successful candidate will work closely with colleagues in Technical Operations, Quality, Regulatory, Discovery, and Development to develop and execute oligonucleotide manufacturing. The individual will also partner with external contract manufacturing organizations as well as author relevant CMC sections for regulatory filings. This is an exciting and unique opportunity to contribute to multiple programs across our portfolio as we tackle a range of therapeutic drug targets.
- Lead the design, development, and optimization of solid-phase synthesis to produce oligonucleotides to support clinical and nonclinical studies.
- Lead and oversee (including hands on) phase appropriate process development for oligonucleotide, linker, and oligonucleotide-linker candidates.
- Stay current with advancements in the field of solid-phase oligonucleotide chemistry and process development, incorporating novel methodologies and technologies into our processes.
- Actively participate in cross-functional project teams, providing expert insights and recommendations to guide project strategy and decision-making.
- Oversee, contract, manage and monitor outsourced manufacturing activities and ensure the timely delivery of the oligonucleotide-linker in compliant manner.
- Write, edit, and finalize CMC sections for regulatory filings.
- Partner with leadership and facilities to build internal oligonucleotide process development capabilities as appropriate.
- PhD in Organic Chemistry, Engineering, or related scientific discipline, with a minimum of 2 to 5 years of relevant biotech/pharmaceutical experience
- Excellent critical thinking and scientific skills and a demonstrated ability to interpret and clearly communicate complex data.
- Experience in process optimization to synthesize small molecules and/or oligonucleotides.
- Experience in the solid phase synthesis and purification of oligonucleotide as well as in analytics for oligonucleotides preferred.
- Experience in managing third party CDMOs to manufacture oligonucleotides under cGMP.
- In-depth understanding of regulatory, compliance, and quality requirements for oligonucleotide-based drugs.
- Demonstrated leadership skills and the ability to work effectively and collaboratively on cross-functional projects teams.
- Excellent oral, presentation, and written communication skills
- Demonstrated ability to multitask and successfully deliver on timelines in a dynamic, fast-paced environment.
- Ability to travel to manage and monitor outsourced activities.
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: $158,000.00 to $206,780.00. 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.