Associate Principal Scientist/Engineer, Medical Device and Combination Products, ISO/DV Testing Manager

The Center for Packaging & Device Analytics (CPDA), within our Manufacturing Division, has responsibility for applied physical, material & analytical science to support production and commercialization of product packaging and drug-delivery medical device/combination-products (MDCPs), such as auto-injectors and pre-filled syringes. We are an interdisciplinary engineering science Center of Excellence that supports the entire global human-health portfolio and partners closely with various Packaging or Device Technology engineering groups, assembly/packaging sites, and partner analytical groups. The CPDA is located at our company's large research and manufacturing site at West Point PA, where our packaging & device laboratories are established.

The CPDA is seeking an Associate Principal Scientist/Engineer for an exciting opportunity to manage and oversee formal MDCP method validation/transfer and design verification testing activities in our dedicated ISO design verification (DV) laboratory [internal] and partner contract laboratories [external]. Responsibilities will include: (1) strategic and tactical (day-to-day) management of design verification testing to support our commercial products to meet critical project timelines, (2) technical oversight of method development, validation, and implementation of analytical methods and associated investigational support at both internal and external laboratories, (3) ensuring safety, environmental and cGMP and ISO 13485 compliance for all laboratory activities and operations, (4) collaborating with CPDA program leads to drive test method development, validation and implementation of new instrumentation/analytical technologies for the laboratory to support current and future commercial MDCP DV testing, and, (5) oversight and technical coaching of CPDA analysts in the ISO laboratory.

To excel in the role, one must be creative and skillful in problem solving and applied experimental physical science relevant to mechanical devices. Key leadership behaviors include communication (written and verbal), collaboration, technical coaching and development with a compliance mindset, and accountability for lab operational excellence and delivery.

• BS, MS or PhD in Mechanical, Chemical or Biomedical Engineering or associated scientific discipline, such as Chemistry.

• A minimum of 3 years with PhD, or 6 years with BS or MS, in an industry role centered on analytical testing.
• Successful work within a cGMP or ISO 13485 certified analytical laboratory.
• Demonstrated competency with mechanical testing.

• Successful manager / supervisor of staff within a cGMP or ISO 13485 certified analytical laboratory.
• Expertise with medical device development and understanding/familiarity of Design Controls (21 CFR 820.30), ISO 13485, cGMP, and relevant industry standards.
• Hands-on experience in MDCP method development, Device Characterization, and Design Verification (DV) for development, engineering studies, design verification, stability studies and/or validation—including analytical strategy and protocol design.
• Advanced expertise with mechanical functionality and strength testing, container closure integrity testing and dimensioning—such as (not limited to) tensile/compression/torsional testing, optical or x-ray microscopy, optical comparator methods, dye ingress testing, etc.

Analytical Development, Analytical Testing, GMP Laboratory, GMP Testing, Interdisciplinary Collaboration, Mechanical Testing, Medical Device Management, Medical Devices, Medical Device Technologies, Medical Device Testing, Synthetic Chemistry, Test Procedure Development