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, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.
Summary: Manages the project leadership team within the Combination Products Development group
Essential Duties and Responsibilities include, but are not limited to, the following:
Education and Experience:
* Manages all combination product development project leads (engineers) and related personnel
* Improves existing systems or leads the development of new systems to assure efficient and correct project outcomes, and regulatory compliance
* Works closely with other combination product development group managers to assure overall program success
* Guides department interactions with key counterparts within the Regeneron organization, including quality assurance, CMC project management, supply chain, and the overall product development team
* Creates new and manages existing relationships with alliance partners and critical vendors
* Identifies opportunities for professional development among the project leads and the broader combination product development group in order to elevate the knowledge and prowess of the team
* Provides leadership to IOPS related to the integration, development, and promotion of device-related endeavors
* Leads the recruitment and development of engineers and managers for the Project Leadership team
* Assures work activities are conducted in a manner compliant with all applicable regulations and industry standards
* Represents IOPS and the devices group at appropriate industry meetings and forums
- Bachelors of Science in the fields of Biomedical Engineering, Mechanical Engineering, Chemical Engineering, or a similar field is required.
- 8+ years of experience is required. Experience in the medical device industry or in the medical device group of a pharmaceutical or biotech company is preferred. Project management experience is strongly preferred. The ideal candidate will have previous management experience.
- Strong technical writing and oral communication skills are required. Experience preparing information for 510(k), BLA, IDE, and PMA submissions is a plus.
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.