Associate Manager/ Manager, Combination Product Development

Rensselaer, New York, US
Oct 09, 2018
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: Manage a combination product cross-functional team with responsibilities in project leadership, technical product engineering, design transfer, and secondary packaging.

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

• Manages a cross-functional team of engineers to assure the delivery of multiple combination product development projects on time, in scope, and within budget.

• Develop and maintain effective interactions with key counterparts within the Regeneron organization, including quality assurance, CMC project management, external manufacturing, and others, including relevant non-IOPS functions.

• Develop a culture of continuous improvement that strives to ensure product safety and efficacy while accelerating delivery of commitments.

• Ensure that products being developed both internally and externally are technically robust through engineering analysis, ensuring that products perform sufficiently and reliably.

• Assures work activities are conducted in a manner compliant with all applicable regulations and industry standards.

• Leads team through investigation efforts and ensures accurately documented investigation reports, supporting data, and conclusions.

• Responsible for identifying opportunities to improve development efficiencies to streamline the device development process from project initiation to design transfer.

• Identifies areas of project risk, escalates issues and risks in an expedient manner, and actively proposes solutions.

• Leads the recruitment and development of engineers for the group.

• Identifies opportunities for professional development among the combination product development group in order to elevate the knowledge and prowess of the team.

• Works closely with other combination product development associate managers (or higher) to assure project success.

• Represents IOPS and the devices group at appropriate industry meetings and forums.

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.

• 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:

• Bachelors of Science in the fields of Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or a similar field is required and 6 years of experience in the medical device industry is required.

• Experience in the development regulated medical devices under Design Control (21 CFR 820) and ISO 14971 is required.

• Previous project management experience is preferred; experience in combination product development is preferred.

Level to be determined based upon experience.

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.