Associate Biotech Production Specialist

*Please note that this would be a 3rd shift position, 10:00 p.m.-8:30 a.m., with potential for double weekends.

Summary

Performs all tasks necessary for the manufacturing operations of both clinical and commercial manufacturing programs.

Responsibilities
• Includes all aspects of biotech production activities related to cell culture
• Assists/contributes in all areas of production as needed
• 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 on equipment
• Monitors production processes
• Participates in equipment start-up, commissioning, and validation activities
• Ensures equipment operational readiness
• Assist 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
• Assist 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
• Ensures all tasks are performed in a manner consistent with safety standards

Education and Experience
• BS/BA in Life Sciences or related field or AS/AAS Degree in Biotechnology/Biological Science. Relevant biotech or pharmaceutical industry experience may be substituted in lieu of educational requirement.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

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