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: Provide technical support for internal late stage and commercial manufacturing processes. The associates provide floor support during operations of manufacturing campaigns, review process data to ensure operational consistency and support for investigations.
Essential Duties and Responsibilities include, but are not limited to, the following:
* Assess manufacturing requirements and capabilities prior to the transfer of new processes into the manufacturing facilities.
* Provide technical support and training of manufacturing personnel to improve understanding of both cell culture and purification operations across the manufacturing organization.
* Assist in the writing and review of manufacturing records, batch sheets and SOPs.
Provide manufacturing descriptions and technical evaluations for regulatory filings and inspections.
* Gather, trend, and analyze process generated data, create process evaluation reports, process transfer documentation, and process characterization presentation.
* Work effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output.
* Ensures all tasks are performed in a manner consistent with safety standards and within cGMP guidelines.
* Build process knowledge base and lessons learned database.
* Provide and schedule floor support in the processing areas during manufacturing operations.
* May support Process Transfers to external facilities). Provide Process Descriptions and Facility Fit Comparisons.
Knowledge and Skills:
* Ability to communicate clearly the timelines and important milestones.
* Ability to adapt to a quickly changing environment.
* Solid knowledge of cGMP and other applicable regulations.
* Ability to effectively communicate issues and ideas with peers and with management.
* Ability to facilitate meetings with cross functional teams.
* Demonstrated interpersonal, written, and oral communication skills.
* Ability to build effective working relationships throughout the organization.
Education and Experience:
*BS in Biological Sciences or Engineering with 2+ years of experience. Title/level will be determined based on skills and experience.
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.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.