Manager External Manufacturing (Drug Product Manufacturing)

Rensselaer, NY, United States
Oct 04, 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: Collaborates with Drug Product Manufacturing Team to ensure business objectives are met through effective support of external manufacturing label and package activities. Ensures all critical external manufacturing requirements are executed to ensure world-class performance of IOPS (Industrial Operations & Product Supply) product supply chains.

Level to be determined based upon qualifications relevant to the role

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

• Ensures that product manufacture occurs in compliance with cGMP and applicable regulations.

• Forms strategic partnerships with technical and operational colleagues to effectively collaborate with other departments and contractors.

• Implements site initiatives in production operation as directed by site management.

• Leads continuous improvements, system implementations and/or strategy development to reduce cycle times and improve efficiencies for area.

• Ensures off-site inspections, testing, and shipping/packaging is done according to guidelines and specifications.

• Overall responsibility for RFPs, purchase requisitions, etc., associated with contractors

• Provide regulatory filing support to IND, BLA, MAA, etc.

• Assist in developing metrics to analyze department activities, workload and performance

• Travel to contractors for overview of operations as needed (25%-50%).

• Manages area through direct reports.

Knowledge, Skills & 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

• Ability to lead and be accountable for team's performance and results

• Manage internal and external relationships

• Develop strategy and create metrics to measure effectiveness of strategy

• Lead through ambiguity and translate into actionable steps

• Provide leadership to direct and indirect reports

• Coaching and conflict resolution

• Handle issues appropriately and with a sense of urgency

• Prioritize based on business needs

• Identify and effectively communicate risks

• Ability to problem solve and identify root cause

• Ability to communicate at all levels and across various functions

• Ability to build, lead, and motivate team

Education and Experience:

• Associate Manager; minimum of BS/BA in business or scientific discipline with 6+ years of related experience in either cGMP manufacturing operations (clinical and/or commercial) or supplier management. MBA preferred.

• Manager; minimum of BS/BA in business or scientific discipline with 7+ years of related experience in either cGMP manufacturing operations (clinical and/or commercial) or supplier management. MBA preferred.

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.