Within this role you will be responsible for providing technical support on the manufacturing process.
You will be a key member in the implementation of large scale commercial manufacturing production program and heavily involved in the technical transfer of processes.
This is a shift position, including day and night shift.
As a Process Specialist Downstream, a typical day might include, but is not limited to, the following: Liaising with the process science/technology transfer teams in relation to the transfer and startup of the downstream manufacturing process Being the key person for technical input into manufacturing records, batch sheets and procedures Writing and reviewing, Standard Operating Procedures or other controlled documents as needed Providing technical input to resolve process problems both on and off the production suites Working closely with other cross functional groups such as Maintenance, Process Sciences, Engineering to resolve process issues and improvements Supporting manufacturing personnel to increase technical knowledge of critical process steps on the floor Supporting Manufacturing personnel on implementing improvements to the process or work systems in the suites.
Supporting RFT programs on the floor Being responsible for modifying process method files through the quality system Supporting CAPA implementation on process related improvements.
Supporting all aspects of the downstream manufacturing process according to approved protocols, regulation, and schedule.
Being involved in Supporting investigations into process variances according to site procedures Communicating well with supervisors regarding changes to the process or material used within the process Interfacing with other departments, such as Facilities, Process Development, Engineering, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control Working to the highest safety standards, supporting safety improvements which require technical input Representing manufacturing during regulatory and client audits Implementing continuous improvement initiatives This role might be for you if: You demonstrate knowledge and experience of of the Downstream Process You possess logical troubleshooting and problem-solving skills You have excellent analytical, written and oral communication skills You demonstrate an ability to work within a successful team To be considered for this opportunity you should have a BS/BA/BEng in Life Sciences or related field and 2+ years of relevant cGMP Manufacturing/Engineering/Scientific experience in a Drug Substance Biotech facility and a deep Technical knowledge of the Downstream Process.
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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.