Associate Biotech Production Specialist

Regeneron Pharmaceuticals•Rensselaer, IN

2d•$22 - $34•Onsite

About The Position

Performs all tasks necessary for the manufacturing operations of both clinical and commercial manufacturing programs. This includes all aspects of biotech production activities related to cell culture, monitoring production processes including cell culture and purification activities for drug substance manufacturing and filling, and inspection and packaging activities for drug product manufacturing. The role also involves reviewing, editing, completing, and revising batch records, logbooks, and SOPs in accordance with cGMP standards, ensuring the availability of production batch records, and performing manufacturing-level maintenance and cleaning of equipment. Additionally, the specialist participates in equipment start-up, commissioning, and validation activities, ensures equipment operational readiness, and assists with troubleshooting in case of equipment failure. The role requires gathering, trending, and analyzing process-generated data, defining robust process parameters, optimizing, trending, and reporting manufacturing process operational parameters, and creating process evaluation reports, process transfer documentation, and process characterization presentations. Training documentation and assisting with the training of new employees are also key responsibilities, along with performing various tests and analytical procedures, in-process sampling, quality control chemistry, and quality control microbiology. The specialist will also keep the process area stocked with essential equipment and components, provide input to production activities scheduling, coordinate regular equipment maintenance and calibrations, and ensure all tasks are performed in a manner consistent with safety standards.

Requirements

BS/BA in Life Sciences or related field or AS/AAS in Biotechnology/Biological Science or equivalent combination of education and experience.
Ability to perform physical requirements for entirety of shift (up to 10 hours): bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation and ability to lift/push/pull up to 50lbs.
Ability to wear full cleanroom attire including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA.
Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire.

Responsibilities

Assists and/or contributes in all areas of production as needed.
Includes all aspects of biotech production activities related to cell culture.
Monitors production processes including cell culture and purification activities for drug substance manufacturing and filling, and inspection and packaging activities for drug product manufacturing.
Reviews, edits, completes and revises completed batch records, logbooks and SOPs in accordance with cGMP standards and compliant with written procedure.
Ensures availability of production batch records for upcoming lots.
Performs manufacturing-level maintenance and cleaning of equipment.
Participates in equipment start-up, commissioning and validation activities.
Ensures equipment operational readiness.
Assists with troubleshooting in case of equipment failure.
Gathers, trends and analyzes process generated data.
Participates in defining robust process parameters during routine manufacturing campaigns.
Works to optimize, trend and report manufacturing process operational parameters during routine manufacturing campaigns.
Creates process evaluation reports, process transfer documentation and process characterization presentations.
Documents all training.
Assists with training of new employees.
Performs various tests and analytical procedures.
Performs in-process sampling, quality control chemistry and quality control microbiology.
Keeps process area stocked with essential equipment and components.
Provides input to production activities scheduling.
Coordinates regular equipment maintenance and calibrations.
Ensures all tasks are performed in a manner consistent with safety standards.