Manager, Device Development & Secondary Packaging

Regeneron Pharmaceuticals•Valley, AL

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. 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.

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.
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.
Manager Combination Product Development: 7+ years of relevant experience
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

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/.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together.

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