Process Specialist

Regeneron Pharmaceuticals, Inc; Munster; On-site; EUR 60,000 - 80,000; Full time

Job summary

A leading biotech company in Ireland seeks a Process Specialist to provide technical support for the manufacturing process, primarily focusing on MES. The ideal candidate should have a BS/BA/BEng in Life Sciences or related field, with over 2 years of relevant cGMP experience. Responsibilities include liaising with teams for process transfer, writing SOPs, and ensuring compliance with safety standards. The company offers an inclusive culture with comprehensive benefits.

Benefits

Health and wellness programs

Fitness centers

Equity awards

Annual bonuses

Paid time off

Qualifications

• Minimum 2+ years of relevant cGMP manufacturing/engineering/scientific experience in a Drug Substance Biotech facility.

Responsibilities

• Provide technical support on the manufacturing process focusing on MES.
• Liaise with Process Science teams related to manufacturing.
• Ensure technical input into Manufacturing records and procedures.
• Resolve process problems on and off production suites.
• Support manufacturing personnel to increase technical knowledge.

Skills

Deep technical knowledge of Downstream Manufacturing Process

Experience in regulatory and client audits

Ability to lead continuous improvement initiatives

Education

BS/BA/BEng in Life Sciences or related field

Job description

Within this role you will provide technical support on the manufacturing process with the focus on MES. You will be a key member in the implementation of large scale commercial manufacturing production program and will be heavily involved in technical transfer of processes.

As a Process Specialist, 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
• Ensuring technical input into Manufacturing records, batch sheets and procedures (MES)
• Writing reviews, 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 or Engineering to resolve process issues and improvements
• Supporting manufacturing personnel to increase technical knowledge of critical process steps on the floor
• Supporting RFT programs on the floor
• 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
• Supporting investigations into process variances according to site procedures
• Communicating with supervisors regarding changes to the process or material used within the process
• Working to the highest safety standards and supporting safety improvements which require technical input

This role might be for you if:

• You have a deep technical knowledge of the Downstream Manufacturing Process
• You have experience representing manufacturing during regulatory and client audits
• You demonstrate an ability to lead continuous improvement initiatives

To be considered for this opportunity you should have a BS/BA/BEng in Life Sciences or a related field and 2+ years of relevant cGMP manufacturing/engineering/scientific experience in a Drug Substance Biotech facility.

#LI-Onsite #JOBSIEPR #IREADV

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.