Biotech Production Specialist - Fill Finish

Location
East Greenbush, New York, United States of America
Posted
Jul 23, 2021
Ref
R127
Required Education
Bachelors Degree
Position Type
Full time
Summary: Performs all tasks necessary for the manufacturing operations of both clinical and commercial manufacturing programs.

*Please note that this will be a 1st shift position (6:00 a.m.-4:30 p.m.,) and 2nd shift (2:00 p.m. -12:30 a.m.)

Essential Duties and Responsibilities include, but are not limited to, the following:
• 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.
• Ensures all tasks are performed in a manner consistent with safety standards.
• Provides input to production activities scheduling.
• Coordinates regular equipment maintenance and calibrations.
• Must be able to push, pull and lift 50 lbs.

Education and Experience:
• Requires BS/BA in Life Sciences or related field or AS/AAS in Biotechnology/Biological Science or equivalent combination of education and experience.

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.