Summary: Performs all tasks necessary for the manufacturing operations of both clinical and commercial manufacturing programs.<br><br>Essential Duties and Responsibilities include, but are not limited to, the following:<br><br><ul><li>Assists and/or contributes in all areas of production as needed.</li><li>Includes all aspects of biotech production activities related to cell culture.</li><li>Monitors production processes including cell culture and purification activities for drug substance manufacturing and filling, and inspection and packaging activities for drug product manufacturing.</li><li>Reviews, edits, completes and revises completed batch records, logbooks and SOPs in accordance with cGMP standards and compliant with written procedure.</li><li>Ensures availability of production batch records for upcoming lots.</li><li>Performs manufacturing-level maintenance and cleaning of equipment. </li><li>Participates in equipment start-up, commissioning and validation activities.</li><li>Ensures equipment operational readiness.</li><li>Assists with troubleshooting in case of equipment failure.</li><li>Gathers, trends and analyzes process generated data.</li><li>Participates in defining robust process parameters during routine manufacturing campaigns.</li><li>Works to optimize, trend and report manufacturing process operational parameters during routine manufacturing campaigns.</li><li>Creates process evaluation reports, process transfer documentation and process characterization presentations.</li><li>Documents all training.</li><li>Assists with training of new employees.</li><li>Performs various tests and analytical procedures.</li><li>Performs in-process sampling, quality control chemistry and quality control microbiology.</li><li>Keeps process area stocked with essential equipment and components.</li><li>Ensures all tasks are performed in a manner consistent with safety standards.</li><li>Provides input to production activities scheduling.</li><li>Coordinates regular equipment maintenance and calibrations.</li><li>Must be able to push, pull and lift 50 lbs.<br><br></li></ul><strong>Education And Experience<br><br></strong>Requires BS/BA in Life Sciences or related field or AS/AAS in Biotechnology/Biological Science or equivalent combination of education and experience.<br><br>Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.<br><br>Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.<br><br>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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.<br><br>For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.<br><br>Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.<br><br><strong><strong>Salary Range (hourly)<br><br></strong></strong>$21.78 - $33.99