Associate Bioprocess Technician (Mon-Thu)
Denali Therapeutics
5 hours ago
On-site
Salt Lake City, UT
Operations
Key Accountabilities / Core Job Responsibilities
- Prepare media and buffers for production campaigns, including media/buffer preparation, equipment and single-use assembly set-up and take-down, and testing and operations.
- Assist with unit operations as requested, including cell culture and purification processes.
- Accurately and comprehensively document manufacturing activities in batch records and document non-conformance issues.
- Perform activities in accordance with company policies and Standard Operating Procedures, global regulatory guidelines, and applicable environmental guidelines.
- Complete assigned training and ensure required GMP training is completed prior to performing GMP activities.
- 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.
- Record work time accurately by clocking in and out using designated timekeeping systems; follow timekeeping policies (overtime, meal breaks, and discrepancy reporting).
Qualifications / Skills (Required)
- High school diploma or GED; typically 3 years of relevant industry experience (advanced degree counts toward relevant experience).
- Trust-building interpersonal skills; authenticity and humility.
- Ability to work effectively in a rapidly changing environment.
- Team-oriented mindset; contribute to a shared purpose and vision.
- Strong self-awareness of how communication and working style affect others.
- Proficient verbal and written communication skills.
- Physical requirements: specialized gowning; lift/manipulate items over 25 lbs; climb ladders; stand for multiple hours.
- Ability to wear PPE (e.g., safety shoes, gloves, eye covering) compliantly for extended periods.
Preferred Qualifications
- Previous manufacturing experience in a regulated industry.
- Experience in product/process support within a regulated setting.
- Experience with Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).
- Prepare media and buffers for production campaigns, including media/buffer preparation, equipment and single-use assembly set-up and take-down, and testing and operations.
- Assist with unit operations as requested, including cell culture and purification processes.
- Accurately and comprehensively document manufacturing activities in batch records and document non-conformance issues.
- Perform activities in accordance with company policies and Standard Operating Procedures, global regulatory guidelines, and applicable environmental guidelines.
- Complete assigned training and ensure required GMP training is completed prior to performing GMP activities.
- 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.
- Record work time accurately by clocking in and out using designated timekeeping systems; follow timekeeping policies (overtime, meal breaks, and discrepancy reporting).
Qualifications / Skills (Required)
- High school diploma or GED; typically 3 years of relevant industry experience (advanced degree counts toward relevant experience).
- Trust-building interpersonal skills; authenticity and humility.
- Ability to work effectively in a rapidly changing environment.
- Team-oriented mindset; contribute to a shared purpose and vision.
- Strong self-awareness of how communication and working style affect others.
- Proficient verbal and written communication skills.
- Physical requirements: specialized gowning; lift/manipulate items over 25 lbs; climb ladders; stand for multiple hours.
- Ability to wear PPE (e.g., safety shoes, gloves, eye covering) compliantly for extended periods.
Preferred Qualifications
- Previous manufacturing experience in a regulated industry.
- Experience in product/process support within a regulated setting.
- Experience with Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).