Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through the application of a deep understanding of degeneration biology and principles of translational medicine.
Reporting to the VP of Clinical Manufacturing, the Associate Director, MSAT will initially be a member of the site leadership team, and a successful hands-on contributor to the build and start-up of Denali’s Utah manufacturing facility. This individual will build and lead a technical and execution team to deliver Denali’s rapidly expanding large molecule pipeline. The Associate Director, MSAT will foster an environment that encourages Denali’s Core Values, innovation and continuous improvement.
- Build and lead a team responsible for technical support and technical transfer of clinical biomolecules
- Partner with process development including technical transfer of processes, process monitoring, process troubleshooting and continuous improvement
- Establish on-site process development lab in collaboration with process development team in South San Francisco
- Develop and author technical content and recipes for digital and paper systems supporting production, including training content
- Partner with Quality to assess deviations, determine root cause and execute preventive and corrective actions
- Education: PhD with at least 6 years of biotech/pharma experience -OR- Masters Degree with at least 10 years of experience -OR- Bachelor’s Degree with at least 12 years of experience in biotech/pharma
- Ability to travel domestically
- Must be able to perform physical activities required for operations in a bioprocess manufacturing environment including donning specialized gowning, standing for long periods and using lifts and ladders.
- The preferred candidate has significant experience in Manufacturing, Process Development, Quality, MSAT, or related disciplines and previous experience in leading and strategy building for a technical operation organization.
- Extensive experience in leading product/process support within a GMP manufacturing setting, leading complex troubleshooting investigations, technology transfer, process development, process monitoring, and process validation.
- Demonstrated experience in CMC development of protein therapeutics at minimum either cell culture process development including fed batch development/optimization or downstream purification development, broad experience including both a plus.
- Direct knowledge of FDA cGMP regulations/requirements for manufacturing clinical biopharmaceuticals.
- Extensive experience with GXP system implementation, procedures and documentation.
- Demonstrated experience building and leading technical teams and developing people
- Demonstrated ability to build trustful and effective relationships
- Ability to lead through uncertainty in a rapidly changing environment
- The ability to build teams where employees have a shared purpose and vision; demonstrated experience building unity between sites and/or functions
- Strong self-awareness of the impact communication and working style has on others
- Understands that authenticity and humility at work are the keys to building trust
- Exceptional influencing, partnership, and collaboration skills across all levels
- Excellent oral presentation and written 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.