Job Description
The Senior Process Scientist supports Process Sciences, Manufacturing, CMC Regulatory and QA Departments through activities and documentation related to implementation and maintenance of in-process control programs for the manufacture of biologics drug substance and formulated drug substance. A typical day might include, but is not limited to, the following: Carrying out lifecycle activities of established IPC programs for manufacturing bioprocesses including impact assessment both on a site specific and global level, change control, and document generation or revision Supporting CMC Regulatory Sciences in development and writing of responses for technical sections of regulatory documents Facilitating and coordinating interdepartmental discussions in support of Process Sciences validation and IPC activities Presenting findings, limit setting and re-evaluation strategies at group, departmental, and interdepartmental meetings as required. Collating and analysing data from development studies, process validation and characterization studies, historical process data, investigative findings and process risk assessments to support the established IPC programs over the lifetime of the molecule. Applying statistical process control tools for re-evaluation of established IPC limit, and monitoring of the manufacturing process Completing and reviewing IPC documentation associated with batch manufacture This role might be for you if: You have strong communication and organizational skills You possess logical troubleshooting and problem-solving skills You contribute to knowledge sharing and process improvement To be considered for this opportunity you should have a BSc/BEng in Life Sciences/Engineering or a related field with 5 years of experience or MSc/MEng in Life Sciences/Engineering or a related field with 4 years of experience or PhD in Life Sciences/ Engineering. cGMP experience is desirable. #JOBSIEST Does this sound like you? Apply now to take your first step towards living the Regeneron Way. We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible 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 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. 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. 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. 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.