Associate Director, MSAT Lead
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.
Reporting to the Executive Director of MSAT and Manufacturing Operations, you will be a successful strategic leader in the build and start-up of Denali’s Utah manufacturing site. You will provide strategic technical and personnel leadership, as well as and serve as a direct contributor to the build, commissioning, execution and technical support of GMP manufacturing to enable the delivery of Denali’s rapidly expanding large molecule pipeline. The Associate Director of MSAT will foster an environment that encourages Denali’s Core Values, innovation, and continuous improvement.
- Hire and build an MSAT team that supports the build, start-up and on-going operation of the manufacturing site, including an MSAT lab.
- Provide process engineering expertise to engineering firms, equipment vendors, and construction resources throughout all project phases (design through construction and startup)
- Provide oversight of and support qualification and validation activities, as well as process technical transfers, at the Salt Lake City site, partnering with the South San Francisco site and CDMOs as required.
- Provide hands-on, technical leadership on the manufacturing floor and lab, while providing mentorship and coaching to junior engineers and operators
- Establish procedures for and support recipe authoring and technical content development for manufacturing processes and procedures
- Establish and maintain the capability to analyze data to monitor manufacturing in real time, support investigations, perform process monitoring, and process optimization
- Ability to work intermittent, on-call schedules as needed to support manufacturing
- Support authoring and review of CMC sections of IND filings relevant to GMP manufacturing
- Ensure MSAT team, in partnership with Quality, can effectively and efficiently assess deviations, determine root cause and execute preventive and corrective actions.
- PhD in Chemical, Mechanical or Biomedical Engineering or related scientific discipline plus a minimum of 7 years of engineering related experience; or BS/MS with a minimum of 12+ years of similarly applicable experience.
- 7+ years in BioPharma Industry experience, preferably in protein therapeutics
- 2+ years managing teams
- Previous experience working in GMP environment and with CMC activities for protein therapeutics
- Ability to travel up to 10% by air and road
- Physical – must be able to put on specialized gowning, lift and manipulate items over 25 lbs, climb ladders, stand for multiple hours at a time
- Clear technical experience in design and operation of bio-processing technologies (cell culture and purification), with experience with single use technologies
- Experience in leading product/process support within a GMP manufacturing setting
- Experience in scale-up and tech transfer of bio-processes
- Direct knowledge of FDA cGMP regulations/requirements for manufacturing clinical biopharmaceuticals
- Experience with regulatory inspections
- Extensive experience with GXP system implementation, procedures, and documentation
- Builds trustful and effective relationships with humility and authenticity
- Confidence to lead through uncertainty in a rapidly changing environment
- The ability to contribute to a team where employees have a shared purpose and vision; foster a “One Denali” environment
- Strong self-awareness of the impact communication and working style has on others
- 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.
Salary Range: $163,000.00 to $187,667.00. 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.