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.
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.
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