-
Job Description
Process Scientist Job Summary
Regeneron is seeking a skilled Process Scientist to support the development and maintenance of in-process control programs for biologics drug substance and formulated drug substance manufacture.
Responsibilities include:
- Carrying out lifecycle activities of established IPC programs, including impact assessment, change control, and document generation or revision
- Supporting CMC Regulatory Sciences in development and writing of responses for technical sections of regulatory documents
- Facilitating interdepartmental discussions in support of Process Sciences validation and IPC activities
- Presenting findings, limit setting, and re-evaluation strategies at meetings
- Collating and analyzing data from development studies, process validation, and characterization studies
- Applying statistical process control tools for re-evaluation of established IPC limits and monitoring of the manufacturing process
- Completing and reviewing IPC documentation associated with batch manufacture
Requirements:
- BSc/BEng in Life Sciences/Engineering or a related field with 5 years of experience or MSc/MEng in Life Sciences/Engineering or a related field with 4 years of experience or PhD in Life Sciences/Engineering
- cGMP experience is desirable
We value:
- Strong communication and organizational skills
- Logical troubleshooting and problem-solving skills
- Contribution to knowledge sharing and process improvement
Regeneron is an equal opportunity employer.
We provide comprehensive benefits, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.