Associate Manager Drug Product Investigations

Location
Rensselaer, NY, United States
Posted
Mar 21, 2019
Ref
15780BR
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: Manages the investigation of process variances involving aseptic filling, container closure materials and manufacturing, and delivery device performance and manufacturing.

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

• Provides technical leadership to internal and external groups in order to complete deviation investigations and disposition of supply.

• Maintains strict adherence to quality system metrics targets and cycle time goals.

• Proposes standardization and business process improvements in order to increase efficiency and timeliness of deviation investigation closure.

• Provides regulatory filing support for drug product (IND, BLA, MAA, etc.), as well as support during regulatory inspection of site quality systems.

• Monitors changing regulatory requirements, industry standards, and best practices for filling, delivery devices, and packaging.

• Ensures developments are communicated within the company and appropriately implemented.

• Serves as the technical liaison between Regeneron Quality Control, Quality Assurance, Operations/Logistics Departments and contract manufacturers or business partners.

• Maintains required training status for staff on Regeneron specific work instructions and SOPs.

• Additional responsibilities as assigned by management.

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

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Education and Experience:

• BS/BA in engineering, materials science, physical or biological sciences or business with 6 years industry experience or MS with 5 years industry experience. Previous supervisory experience of others required.

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.