Job Description
Job Description Summary:
Support Process Sciences, Manufacturing, CMC Regulatory and QA Departments through in-process control programs for biologics drug substance and formulated drug substance.
Carry out lifecycle activities including impact assessment, change control, and document generation/revisions.
Support CMC Regulatory Sciences in development and writing of responses for technical sections of regulatory documents.
Facilitate interdepartmental discussions and present findings at meetings.
Collate and analyze data from development studies, process validation, and characterization studies.
Apply statistical process control tools for re-evaluation of IPC limits.
Complete and review IPC documentation associated with batch manufacture.
Requirements:
Strong communication and organizational skills.
Logical troubleshooting and problem-solving skills.
Contribute to knowledge sharing and process improvement.
Qualifications:
BSc/BEng in Life Sciences/Engineering or related field with 5 years experience.
MSc/MEng in Life Sciences/Engineering or related field with 4 years experience.
PhD in Life Sciences/Engineering.
cGMP experience desirable.
About Regeneron:
Inclusive and diverse culture.
Comprehensive benefits including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off.
Equal opportunity employer.
Important Notice:
Regeneron provides reasonable accommodation to known disabilities or chronic illnesses.
Background checks will be conducted as part of the recruitment process.
Disclaimer:
Salary ranges provided in accordance with U.S. law for U.S. positions.
Salary ranges provided in accordance with local law and currency for Japan and Canada positions.