Associate Product Specification Specialist

Rensselaer, New York, US
Jul 13, 2018
Required Education
Bachelors Degree
Position Type
Full time
Position Summary

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: The Product Specification Specialist will contribute to the content of Product Specification Documents by collaborating with other departments, and working within Regeneron's Quality Systems to create and maintain these controlled documents.

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

• Works within Regeneron's Quality Systems to initiate, revise or retire product specifications while keeping compliant with site procedures.

• Collaborates with cross-functional departments to understand the content to be included in new and revised Product Specification documents.

• Works with associated departments to determine the impact of the changes to Product Specification Documents and conducts Quality Risk Management assessments to identify failure modes and risk controls.

• Collaborate with appropriate personnel to ensure product specifications are consistent with current regulatory filings and commitments.

• Other duties as required.

Knowledge and Skills:

• Self-motivation and the ability to effectively organize and manage work responsibilities at an independent level.

• Good time management and project management skills with the ability to multitask and deal with changing priorities are a must for the position.

• Ability to meet deadlines.

• Good interpersonal, written and oral communication skills are required. Ability to present in front of groups and actively participate in cross functional department meetings.

• Computer skills include: Hands-on knowledge of MS word, PowerPoint, Excel, ability to learn and navigate document management software

• Ability to work well in a team setting.
Education and Experience:

• Requires a BS/BA in a scientific discipline along with 2 years of relevant work experience. . Experience with or knowledge of biopharmaceutical testing or manufacturing preferred. Knowledge of USP/EP compendia requirements and ICH guidelines a plus. Will substitute relevant experience for education requirements.

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.