Regeneron is seeking a Manager, Combination Product Development, to join our Process Sciences—Drug Product Engineering team. In this role, you will lead the device product development group with a focus on secondary packaging, driving the development and advancement of drug delivery devices that address emerging needs across Regeneron’s product pipeline.

As a Manager, Combination Product Development a typical day might include the following:

• Own technical performance for a team delivering off the shelf and custom secondary packaging solutions for regulatory and commercial needs.
• Ensure technically robust packaging via engineering analyses, reliability, and performance assessments.
• Define design inputs and rationales; translate requirements into clear technical specifications.
• Collaborate with suppliers to develop and qualify packaging design outputs.
• Oversee product characterization and Design Verification testing connected to packaging.
• Author protocols and technical reports to support development milestones.
• Define essential performance requirements and traceability to design outputs.
• Establish development control strategies, including statistically based, risk driven sampling plans.
• Support regulatory filings (IND, BLA, MAA) for drug products.
• Lead and develop a cross functional engineering team; recruit, coach, and grow talent.
• Manage multiple projects to deliver on time, in scope, and within budget.
• Partner with peer managers to ensure program success; escalate and resolve technical risks quickly.
• Build strong interfaces with internal design, QA, external manufacturing, and broader engineering teams.
• Champion design controls and technical excellence across IOPS.
• Build organizational standards and systems to scale development for a growing product portfolio.
• Define and integrate standard design and development procedures with Regeneron business and quality systems.
• Identify and implement improvements to streamline device product development and cross team interfaces.
• Represent the combination product device development group at industry forums.
• Monitor evolving regulations, standards, and best practices.
• Develop and maintain relationships with vendors, partners, and key opinion leaders.

This role might be for you if you:

• Possess strong technical writing and oral communication skills.
• Have experience with secondary packaging product design including cartons, carton inserts, blister trays and Tyvek lids, product and package labeling.
• Enjoy developing, mentoring and coaching a team.
• Have experience with different common secondary manufacturing technologies for secondary packaging and labeling.
• Have experience with tolerance and mechanical stack analysis and other engineering analysis tasks.
• Have knowledge and experience utilizing design of experiments or other problem-solving methodologies during product development.

To be considered for the Manager, Combination Product Development you must be willing and able to work Monday- Friday, 8am-4:30pm and travel occasionally. You must have a B.S in Biomedical Engineering, Mechanical Engineering, Chemical Engineering or related field. For various levels you must have the following:

• Associate Manager Combination Product Development: 6+ years of relevant experience
• Manager Combination Product Development: 7+ years of relevant experience

Previous experience within packaging & combination product development is preferred. Previous people leadership/ supervisory experience is required. Level is determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$92,200.00 - $176,000.00