Director, Oligonucleotide Development and Manufacturing
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.
In anticipation of the Company’s growth plans, Denali Therapeutics is seeking to recruit a Director of Oligonucleotide Development and Manufacturing. The Director of Oligonucleotide Development and Manufacturing will provide strategic direction for oligonucleotide and oligonucleotide-linker development and manufacturing from early to late-stage development. S/he will work in close collaboration with colleagues in Therapeutic Discovery, Technical Operations, Quality and Compliance, and Regulatory. The individual will be responsible for overseeing and managing all oligonucleotide process & analytical development and manufacturing activities, both internally and externally performed. In addition, this individual will write, edit, and finalize CMC sections of global regulatory filings and will play a key role in interactions with health authorities.
- Provide leadership and develop CMC strategies for oligonucleotide-related clinical candidates
- Lead and oversee (including hands on) phase appropriate process and analytical development for oligonucleotide, linker and oligonucleotide-linker candidates in development
- Collaborate with Discovery, Large Molecule CMC Development, Quality and Program Management functions to deliver oligonucleotide and oligonucleotide-linker (GLP and GMP) to support all nonclinical and clinical programs. Plan and allocate resources
- Foster innovative mindset and continuously improve Denali’s technical and scientific capabilities by demonstrating new technologies and skills as needed
- Review, edit, and finalize RFPs as well as protocols, amendments, and reports that meet global regulatory and compliance requirements. Execute the oligo-linker manufacturing campaigns at external CDMOs
- Write, edit, and finalize CMC sections for regulatory filings
- Oversee, contract, manage and monitor outsourced manufacturing activities and ensure the timely delivery of the oligonucleotide-linker in compliant manner
- Build internal oligonucleotide process and analytical development capabilities as appropriate
- PhD in Chemistry, Engineering or related scientific discipline, with a minimum of 8 years of relevant biotech/pharmaceutical experience
- Strong knowledge in the solid phase synthesis and purification of oligonucleotide as well as in analytics for oligonucleotides.
- Experience in selecting and managing third party CDMOs to manufacture oligonucleotides under cGMP. Extensive experience with outsourcing and vendor management.
- Excellent critical thinking and scientific skills and a demonstrated ability to interpret and clearly communicate complex data.
- 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; an ability to multitask and successfully deliver on timelines in a dynamic, fast-paced environment
- Ability to thrive in a multi-tasking and complex environment with limited resources and have flexibility to adapt to changing demands or priorities based on corporate goals.
- 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: $215,000.00 to $243,000.00. 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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