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.
Responsibilities
Lead the design of automation software and strategies (process and supervisory control, electronic batch records, data collection, building management and other auxiliary systems).
Support building utilities and manufacturing equipment with a focus on building automation systems, HVAC, water systems, cell culture and purification processing.
Interface with manufacturing and other end users of the system and implement necessary changes to improve the system's overall efficiency including training.
Provide technical direction to engineering firms, equipment vendors, support contractors and construction resources including vendor acceptance testing and startup validation.
Develop standard operating procedures including supporting recipe authoring and technical content development for digital systems while working with automation processes and systems.
Partner with Quality to assess deviations, determine root cause and execute preventive and corrective actions.
Requirements
BS in Engineering.
10+ years of manufacturing industry experience, biopharmaceutical or medical device manufacturing preferred.
Extensive experience in leading product processing equipment support following FDA cGMP regulation requirements manufacturing setting.
Extensive experience deploying and supporting digital systems for manufacturing support including IT/OT interface, PLC programming.
Ability to work intermittent, on-call schedules as needed to support manufacturing.
Ability to travel up to 10% by air and road.
Demonstrated experience collaborating within technical teams.
Builds trustful and effective relationships with authenticity and humility.
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.
Physical requirements– must be able to put on specialized gowning, lift and manipulate items over 25 lbs, climb ladders, stand for multiple hours at a time.
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.
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