Bioprocess Technician

Role Summary

Oversee cell culture to purification operations, including media and buffer preparation, equipment setup, and process validation, while documenting activities and non-conformances in accordance with GMP standards and company policies. Collaborate with cross-functional teams to optimize processes, support technical transfers, review manufacturing procedures, and assist in root cause analysis for deviations. Maintain up-to-date training for GMP activities and be flexible with work hours to meet business needs.

Responsibilities

• Responsibilities span from cell culture through purification. 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.
• Support startup validation activities for new equipment and shake-down of new processes
• Document all manufacturing activities accurately and comprehensively in batch records
• 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
• Assist in technical transfers to enable production of new clinical processes
• Support recipe review and technical content development for manufacturing processes and procedures
• Partner with Quality and other departments to assess deviations, determine root cause and execute preventive and corrective action
• Responsibilities require a work schedule that may include working outside of normal work hours, in order to meet business demands such as weekends/Holidays (rotating schedule)
• 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

• Required: High school diploma or GED and 4 years of relevant industry experience or Associate or Bachelor degree in relevant scientific discipline
• Required: Builds trustful and effective relationships with authenticity and humility
• Required: Confidence to work in a rapidly changing environment
• Required: The ability to contribute to a team where employees have a shared purpose and vision; foster a “One Denali” environment
• Required: Strong self-awareness of the impact communication and working style has on others
• Required: Proficient verbal and written communication skills
• Required: 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
• Required: 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

Preferred Qualifications

• BioPharma Industry experience related to protein therapeutics, particularly operation of bio-processing technologies (cell culture and purification)
• Experience in product/process support within a GMP manufacturing setting
• Experience with single use technologies

Additional Requirements

• Note: This section may include travel or other physical demands if essential to the role.