Manager, Device Development & Secondary Packaging

Regeneron Pharmaceuticals • Valley, AL

8d • $92,200 - $176,000 • Onsite

About The Position

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.

Requirements

• 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.
• Must be willing and able to work Monday- Friday, 8am-4:30pm and travel occasionally.
• Must have a B.S in Biomedical Engineering, Mechanical Engineering, Chemical Engineering or related field.
• 7+ years of relevant experience (for Manager level).
• Previous people leadership/ supervisory experience is required.

Nice To Haves

• Previous experience within packaging & combination product development is preferred.

Responsibilities

• 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.

Benefits

• 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
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager