Assoc Biotech Production Specialist

Regeneron Pharmaceuticals • Rensselaer, IN

1d • $22 - $35 • Onsite

About The Position

Performs tasks necessary for manufacturing operations supporting clinical and commercial programs. The role contributes across biotech production activities related to cell culture, including monitoring cell culture and purification for drug substance manufacturing, and filling, inspection, and packaging for drug product manufacturing. It supports equipment readiness and maintenance, production documentation, process data analysis and optimization, testing and sampling, training, scheduling, and safety. Work requires wearing full cleanroom attire and meeting the physical demands of the shift.

Requirements

• BS/BA in Life Sciences or a related field, or AS/AAS in Biotechnology/Biological Science, or an equivalent combination of education and experience.
• Ability to meet the physical requirements for the entirety of a shift of up to 10 hours, including bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, and hand manipulation.
• Ability to lift, push, or pull up to 50 pounds.
• Ability to wear full cleanroom attire and use sanitizing agents during gowning.
• Ability to remove jewelry, makeup, and nail adornments when wearing cleanroom attire.

Responsibilities

• Assist with production activities as needed, including biotech production tasks related to cell culture.
• Monitor cell culture and purification activities for drug substance manufacturing and filling, inspection, and packaging activities for drug product manufacturing.
• Review, edit, complete, and revise batch records, logbooks, and SOPs in accordance with cGMP standards and written procedures.
• Ensure production batch records are available for upcoming lots.
• Perform manufacturing-level equipment maintenance and cleaning.
• Participate in equipment start-up, commissioning, and validation activities, and ensure equipment is operationally ready.
• Assist with troubleshooting equipment failures.
• Gather, trend, and analyze process-generated data.
• Participate in defining robust process parameters during routine manufacturing campaigns.
• Optimize, trend, and report manufacturing process operational parameters during routine manufacturing campaigns.
• Create process evaluation reports, process transfer documentation, and process characterization presentations.
• Document training and assist with training new employees.
• Perform tests and analytical procedures, including in-process sampling, quality control chemistry, and quality control microbiology.
• Keep the process area stocked with essential equipment and components.
• Provide input to production scheduling.
• Coordinate regular equipment maintenance and calibrations.
• Perform all tasks consistently with safety standards.

Benefits

• Annual bonuses or other incentive plans, depending on country and role
• Equity awards, depending on country and role
• Pension or retirement benefits, depending on country and role
• 401(k) company match, depending on country and role
• Health and wellness programs, depending on country and role
• Fitness centers, depending on country and role
• Insurance benefits, including medical, dental, vision, life, and disability, depending on country and role
• Paid time off, depending on country and role
• Family support benefits, depending on country and role

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level