Associate Manager Product Specifications

Rensselaer, NY, United States
Jul 16, 2019
Required Education
Bachelors Degree
Position Type
Full time
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: Responsible to oversee and actively manage the product specification process, working with, and serving as a liaison to other departments that are stakeholders of product specification documents.

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

• Oversees and supervises the daily operations of the Product Specification Team.

• Prioritizes tasks with respect to supply needs, regulatory submissions, and other quality system requirements.

• Learns and becomes proficient in all aspects of specification creation and revision processes, including change control requirements and document control quality systems.

• Ensures that these processes for the creation, revision, and retirement of product specifications are effective and well-coordinated.

• Ensures that all content of product specifications is current, accurate, and appropriate by being involved in the review, editing and approval of product specifications.

• Collaborates cross-functionally to perform statistical analysis of data when setting specifications.

• Participates in development team meetings.

• Leads other projects as determined by Department Management.

• Supervises and provides guidance to the Product Specification Specialists, which may include assisting with coverage of administrative tasks, as needed.

Knowledge, Skills, Abilities:

• Direct experience in product specifications writing.

• Experience initiating and leading process improvement efforts in past role(s).

• Strong communication skills, including experience facilitating decision-making across multiple stakeholders/functional areas and senior leadership.

• Demonstrated experience building effective and high-performing teams.

Education and Experience:

• Requires a BS/BA in a Life Science or related field, along with 6+ years of progressive, relevant experience.

• Leadership or supervisory experience is required.

• Experience with biopharmaceutical testing or manufacturing is required.

• Experience with change control and document control quality systems is strongly desired.

Title level (Associate Manager or Manager) will be determined based on qualifications relevant to the role.

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.