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Process Scientist - IPC Lifecycle Management

Limerick, Country: Ireland
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Job Description

Position Summary

Summary: Supports, develops and maintains in-process control (IPC) programs for manufacturing bioprocesses as part of Process Sciences Department.

Essential Duties and Responsibilities may include, but are not limited to, the following:

  • Collates and analyzes data from development studies, process validation and characterization studies, historical process data, investigative findings and process risk assessments to develop In-Process Control (IPC) programs.

  • Applies statistical process control tools for limit establishment and monitoring of the manufacturing process.

  • Contributes to scientific analysis of results generated from laboratory-scale, and manufacturing-scale studies, including determination of possible mechanisms of process behavior in cell culture and/or purification systems.

  • Communicate information on current process data and other IOPS initiatives which may impact process development and/or technology transfer.

  • Participates in process and quality risk assessments.

  • Presents findings, limit setting strategies, and process monitoring data at group, departmental, and interdepartmental meetings as necessary.

  • Assists in troubleshooting activities associated with the manufacturing process.

  • Supports technology transfer activities as needed.

  • Support CMC Regulatory Sciences in developing and writing of responses for technical sections of regulatory documents.

  • Presents findings at group and interdepartmental meetings.

Education and Experience:

  • PhD in Biotechnology, Biochemistry or a related field with 0-2 years’ experience; or MSc in Biotechnology, Biochemistry or a related field with 4+ year’s relevant experience; may consider another discipline with added relevant experience. cGMP experience is desirable.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

Job Settings
Number of jobs: 1 hires
Information about the advertiser
Company: Regeneron
Company size: 1-49
Contact: NA