Associate Bioprocess Technician (6 Month Term Role/Thursday-Sunday Shift)

Role Summary

Associate Bioprocess Technician (6 Month Term Role/Thursday-Sunday Shift) at Denali Therapeutics. Responsible for media and buffer preparation and introduction to cell culture and purification processes as part of production campaigns. Work involves equipment setup/takedown, documentation, and collaboration across cross-functional teams to optimize manufacturing processes while adhering to GMP and company policies.

Responsibilities

• Media and buffer preparations for production campaigns, including setup and takedown of equipment and single-use assemblies, and both testing and actual operations.
• Introduction to unit operations such as cell culture and purification processes as requested.
• Document all manufacturing activities accurately in batch records and document all non-conformance issues.
• Operate in accordance with company policies, SOPs, regulatory guidelines, and environmental guidelines as appropriate.
• Stay up to date on assigned training and complete any GMP-related training prior to execution.
• Collaborate with cross-functional teams to optimize manufacturing processes and improve efficiency.
• Partner with Quality and other departments to assess deviations, determine root cause, and execute preventive and corrective actions.
• Accurate and timely recording of work time in designated timekeeping systems; adhere to timekeeping policies and reporting procedures for discrepancies.

Qualifications

• Required: High school diploma or GED and 2 years of relevant industry experience; advanced degree in a relevant field considered towards experience.
• Required: Ability to build trustful and effective relationships with authenticity and humility.
• Required: Confidence to work in a rapidly changing environment.
• Required: Ability to contribute to a team with a shared purpose and foster a “One Denali” environment.
• Required: Strong self-awareness of how communication and working style impact others.
• Required: Proficient verbal and written communication skills.
• Required: Physical ability to wear specialized gowning, lift and manipulate items over 25 lbs, climb ladders, and stand for extended periods.
• Required: Ability to wear PPE (e.g., safety shoes, gloves, eye protection) for extended periods.
• Required: Must be able to work Thursday through Sunday shift.
• Preferred: Previous manufacturing experience in a regulated industry.
• Preferred: Experience in product/process support within a regulated setting.
• Preferred: Experience with Good Documentation Practices and Good Manufacturing Practices.

Skills

• Proficient verbal and written communication
• Collaborative and team-oriented mindset
• Attention to detail in documentation and record-keeping

Education

• Not specified

Additional Requirements

• Must be able to work the Thursday-Sunday shift.