Drug Production, Associate Manufacturing Specialist (Overnights)

About the role

Cover all facets of drug production in a clean room including cell culture and purification of monoclonal antibodies.

Complete and review batch records and logbooks in accordance with Current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP).

Perform in-process sampling and analysis of buffer solutions, cell culture, and drug substance.

Operate automated equipment such as bioreactors, chromatography columns, and filtration skids.

Support equipment start-up, troubleshooting, and validation.

Partner with R&D teams to implement new drug manufacturing processes and technologies.

Work in a fast-paced setting where your priorities can quickly change based on the needs of the business and our patients.

Operate in a highly regulated environment, striving to continuously improve processes and maintain compliance to manufacture safe and effective medicines for patients.

Use computerized systems for daily performance of tasks.

Responsibilities

• Cover all facets of drug production in a clean room including cell culture and purification of monoclonal antibodies.
• Complete and review batch records and logbooks in accordance with cGMP and SOP.
• Perform in-process sampling and analysis of buffer solutions, cell culture, and drug substance.
• Operate automated equipment such as bioreactors, chromatography columns, and filtration skids.
• Support equipment start-up, troubleshooting, and validation.
• Partner with R&D teams to implement new drug manufacturing processes and technologies.
• Work in a fast-paced setting where your priorities can quickly change based on the needs of the business and our patients.
• Operate in a highly regulated environment, striving to continuously improve processes and maintain compliance to manufacture safe and effective medicines for patients.
• Use computerized systems for daily performance of tasks.

Requirements

• HS diploma + 4 years of relevant work experience is required.
• Or AS, BS or BA in Life Sciences or related field.

Qualifications

• Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire.
• Ability to perform physical requirements for entirety of shift (up to 10 hours) in a clean room environment.
• Some physical requirements can include but not limited to: bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation and ability to lift/push/pull up to 50lbs.

Skills

• Knowledge of current good manufacturing practices (cGMP) and standard operating procedures (SOP).
• Ability to operate automated equipment such as bioreactors, chromatography columns, and filtration skids.
• Strong problem-solving and troubleshooting skills.
• Excellent communication and teamwork abilities.

Benefits

• Student loan paydown program & tuition reimbursement.
• Family care benefits.
• Relocation assistance.
• Inclusion, culture and well-being programs (including physical & mental health).

Pay

$21.78 - $39.13 per hour

Schedule

3rd shift, 10pm-8:30am with the potential for 1-2 weekend days