Bioprocessing Manufacturing Associate (6 Month Term Role/Thursday-Sunday Shift)

Role Summary

Bioprocessing Manufacturing Associate (6 Month Term Role/Thursday-Sunday Shift)

Responsibilities

• Responsibilities span across media and buffer preparations for production campaigns. This includes, but is not limited to, media and buffer preparation, set-up and take-down of equipment and single-use assemblies, and both testing and actual operations.
• Introduction to unit operations as requested which include but not limited to cell culture and purification processes.
• Document all manufacturing activities accurately and comprehensively in batch records and document all non-conformance issues
• 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
• 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 action
• Accurate and timely recording of work time by clocking in and out using designated timekeeping systems. Adherence to company timekeeping policies, including rules regarding overtime, meal breaks, and reporting procedures for any discrepancies.

Qualifications

• High school diploma or GED and 2 years of relevant industry experience. Advanced degree in relevant field of study will be considered towards relevant industry experience.
• 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 ‚ÄúOne Denali‚Äù environment
• Strong self-awareness of the impact communication and working style has on others
• Proficient verbal and written communication skills
• Physical ‚Äì 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 be able to work Thursday through Sunday shift

Preferred Qualifications

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