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 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 not limited to, the following:
Liaises with the process science/technology transfer teams in relation to the transfer and startup of the downstream manufacturing process.
Key person for technical input into Manufacturing records, batch sheets and procedures.
Writes, reviews, Standard Operating Procedures or other controlled documents as needed.
Provides technical input to resolve process problems both on and off the production suites
Work closely with other cross functional groups such as Maintenance, Process Sciences, Engineering to resolve process issues and improvements.
Supports manufacturing personnel to increase technical knowledge of critical process steps on the floor.
Supports Manufacturing personnel on implementing improvements to the process or work systems in the suites.
Supports RFT programs on the floor
Responsible for modifying process method files through the quality system.
Supports CAPA implementation on process related improvements.
Supports all aspects of the downstream manufacturing process according to approved protocols, regulation, and schedule.
Can be involved in Supporting investigations into process variances according to site procedures.
Communicates well with supervisors regarding changes to the process or material used within the process.
Interfaces with other departments, such as Facilities, Process Development, Engineering, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control.
Works to the highest safety standards. Supports safety improvements which require technical input.
Represents manufacturing during regulatory and client audits.
Implements 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. 2+ years of relevant cGMP manufacturing/engineering/scientific experience in a Drug Substance Biotech facility and a deep Technical knowledge of the Downstream Process.
#IRELIM #LI-Onsite #JOBSIEST #IRELIM #REGNIELSM
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.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.
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.