Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases. Summary:
Performs all tasks necessary for the manufacturing operations of both clinical and commercial manufacturing programs.Essential Duties and Responsibilities include, but are not limited to, the following:
- Includes all aspects of biotech production activities related to cell culture
- Assists/contributes in all areas of production as needed.
- Reviews, edits, completes, and revises completed batch records, Logbooks, and SOPs in accordance with cGMP standards and compliant with written procedure.
- Ensures availability of production batch records for upcoming lots.
- Performs manufacturing level maintenance on equipment.
- Monitors production processes.
- Participates in equipment start-up, commissioning, and validation activities.
- Ensures equipment operational readiness
- Assist with troubleshooting in case of equipment failure.
- Gathers, trends, and analyzes process generated data.
- Participates in defining robust process parameters during routine manufacturing campaigns.
- Works to optimize, trend, and report manufacturing process operational parameters during routine manufacturing campaigns.
- Creates process evaluation reports, process transfer documentation, and process characterization presentations.
- Documents all training;
- Assist with training of new employees.
- Performs various tests and analytical procedures.
- Performs in-process sampling, Quality Control Chemistry and Quality Control Microbiology.
- Keeps process area stocked with essential equipment and components.
- Ensures all tasks are performed in a manner consistent with safety standards.
- Must be able to lift/push/pull at least 50lbs.
Education and Experience:
Level I – Associates degree in Life Science, Engineering, or related discipline
Level II – Bachelors in Life Science, Engineering, or related discipline
Relevant biotech or pharmaceutical industry experience may be substituted in lieu of educational requirement.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron’s unwavering commitment to combining good science & good business.