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Rensselaer, New York - USD Full Time Posted: Friday, 14 February 2020
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, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: Supports serialization initiatives for Regeneron to stay compliant with product identification related regulations in the US, EU and other markets with a focus on supporting the Optel OSM (Open SiteMaster). Keeps track of the changing regulatory landscapes in different markets, streamlines serialization related activities for new product launch. Works closely with functional departments to configure, support and troubleshoot the OSM to ensure completion of installation and qualification to go live. Works closely with cross functional teams to support product launch and ongoing daily production of drug products for Regeneron.

Level to be determined based on qualifications relevant to the role

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

Supports the implementation, validation and daily operation of the Optel OSM system.

Assists IT with serialization validation documentation including creation of functional, design specifications and Test plans.

Provides ongoing support and maintenance of the OSM during commercial production.

Acts as the primary resource and the serialization SME for the site.

Coordinates planning and scheduling of patches, upgrades and maintenance with vendor technicians.

Assists the team with creation of Change controls, unit testing, integrated or block testing and end-to-end testing.

Performs ad-hoc analysis and supports special projects.

Keeps leadership in stakeholder functions apprised of project status, scope and challenges.

Knowledge, Skills and Abilities:

Ability to maintain integrity and honesty at all times

Ability to work independently or as part of a team

Ability to communicate with transparency

Continuously drive to improve processes for improved performance

Demonstrate respectful behavior at all times

Sets priorities

Ability to work in an ever-changing environment

Builds strong working relationships cross-functionally

Communicates with transparency and active listening

Education & Experience:
  • Associate Analyst - BA/BS (Business, Information Systems, or a scientific discipline) along with 0-2 years' experience in IT system implementations in pharmaceutical/biotech/manufacturing environment.
  • Analyst - BA/BS (Business, Information Systems, or a scientific discipline) along with 2+ years' experience in IT system implementations in a pharmaceutical/biotech/manufacturing environment.
  • May substitute relevant industry experience in lieu of education.
  • Masters' degree (Business Administration) a plus.
  • Business Analysis, Project Management experience a plus.
  • Previous experience with serialization and/or pharmaceutical packaging a plus.

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, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.

Rensselaer, New York, United States of America
Regeneron Pharmaceuticals, Inc.
Regeneron Pharmaceuticals, Inc.
2/14/2020 8:39:26 AM

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