What are the responsibilities and job description for the Principal Scientist, Process Chemistry, Oligonucleotide and SM CMC position at Denali Therapeutics?
Neurodegenerative diseases are one of the largest medical challenges of our time. Denali Therapeutics is a biotechnology company dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. 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.
Design, develop, and oversee scalable synthetic routes for drug substance manufacturing, manage CMC activities with external CDMOs, and ensure regulatory compliance. Collaborate with formulation teams, foster innovation, and provide technical recommendations while effectively managing multiple projects and communicating within project teams.
Key Accountabilities / Core Job Responsibilities :
- Design, perform, and oversee phase-appropriate synthetic route assessment and development including synthetic route identification and scale-up for nGLP, GLP and GMP manufacturing for oligonucleotides and small molecules
- Build, expand and safely operate internal oligonucleotide process laboratory capabilities
- Explore new and innovative technologies to enable cost-effective high-volume oligonucleotide production
- Collaborate with discovery scientists, manufacturing and project teams to advance our portfolio and manufacturing strategies and ensuring timely technology transfer and flow of information
- Develop synthetic plans for the scaleable synthesis of oligonucleotides & small molecules
- Plan, oversee, and deliver drug substance to support oligonucleotide & small molecule nonclinical and clinical programs
- Write and transfer developed technology to external CDMO's and work with suppliers to solve process chemistry challenges to ensure delivery of material
- Oversee, contract and manage outsourced CMC activities and ensure the timely delivery of drug substance and that all regulatory and compliance requirements are met
- Foster innovative mindset and continuously improve the technical and scientific process chemistry capabilities by demonstrating new technologies and skills.
- Generate effective hypotheses to pursue synthesis or manufacturing goals and develop innovative solutions to overcome synthetic and manufacturing obstacles
- Identify broad implications of findings and revise strategies to meet process development goals and timelines
- Lead direct report(s) through annual goal setting, growth planning, adherence to company policies, maintain training compliance and provide ongoing feedback on growth, development and areas of improvement.
Qualifications and Skills :
Salary Range : $180,000.00 to $214,600.00 . 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.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.
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 : $180,000 - $214,600
