Associate Manufacturing Engineer (Thur-Sun)

Denali Therapeutics•Salt Lake City, UT

About The Position

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. The Associate Manufacturing Engineer’s responsibilities span from across Upstream/Downstream Unit Operations for both support and execution of manufacturing activities. Key Accountabilities/Core Job Responsibilities: Schedule Monday through Thursday with ability to alter schedule based on critical unit operation needs. Responsibilities span across upstream and downstream for production campaigns and provide oversight of critical unit operations as area subject matter expert and provide continuous process sustainment activities to ensure process are in a state of control. Coordinating with stakeholders to align activities to enable execution of production schedule (i.e. release of batch records, ensure Bill of Material (BOM) accuracy, etc.) Ability to perform complex problem solving for both process and equipment related issues. Work with vendors when needed to bring equipment back into GMP state when issues arise. Initiate Deviations and partner with Quality and other departments for investigations, impact assessment, determine root cause and execute preventive and corrective actions. Collaborate with Process Engineering and MSAT for asset induction and develop subject matter expertise for ability to carry on sustainment responsibilities for the asset in question. Lead implementation for process improvements and procedural updates. Partner with MSAT on satellite and GLP processes in MSAT lab where applicable. Review completed batch records and coordinate with QA for record closure. Scheduling activities for routine maintenance required on assets based on availability and timing for CAL/PM due dates. Conduct all activities in accordance with company policies & Standard Operating Procedures, global regulatory guidelines, environmental guidelines, as appropriate, etc. Remain up to date on all assigned training and ensure completion of any training required for GMP activities prior to executing those activities

Requirements

Bachelor’s degree in a Chemical, Mechanical or Biomedical Engineering or related relevant scientific or technical discipline with 1–2 years of applicable industry experience preferred.
An advanced degree (MS or higher) in a related field may substitute for some or all the required experience. Relevant disciplines include, but are not limited to, Biology, Biochemistry, Chemistry, Biotechnology, or related life sciences.
Builds trustful and effective relationships with authenticity and humility.
Confidence to work 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.
Proficient verbal and written communication skills.
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.
Must be able to wear personal protective equipment (e.g., safety shoes, gloves, eye covering, etc.) in a compliant manner for extended periods of time.
Must have the ability to work Thursday through Sunday as regular shift schedule.

Nice To Haves

Previous bio-manufacturing experience in a regulated industry.
Experience in product/process support within a regulated setting.
Experience with Good Documentation Practices and Good Manufacturing Practices.

Responsibilities

Responsibilities span across upstream and downstream for production campaigns and provide oversight of critical unit operations as area subject matter expert and provide continuous process sustainment activities to ensure process are in a state of control.
Coordinating with stakeholders to align activities to enable execution of production schedule (i.e. release of batch records, ensure Bill of Material (BOM) accuracy, etc.)
Ability to perform complex problem solving for both process and equipment related issues.
Work with vendors when needed to bring equipment back into GMP state when issues arise.
Initiate Deviations and partner with Quality and other departments for investigations, impact assessment, determine root cause and execute preventive and corrective actions.
Collaborate with Process Engineering and MSAT for asset induction and develop subject matter expertise for ability to carry on sustainment responsibilities for the asset in question.
Lead implementation for process improvements and procedural updates.
Partner with MSAT on satellite and GLP processes in MSAT lab where applicable.
Review completed batch records and coordinate with QA for record closure.
Scheduling activities for routine maintenance required on assets based on availability and timing for CAL/PM due dates.
Conduct all activities in accordance with company policies & Standard Operating Procedures, global regulatory guidelines, environmental guidelines, as appropriate, etc.
Remain up to date on all assigned training and ensure completion of any training required for GMP activities prior to executing those activities