• The Associate Principal Scientist will lead the definition and execution of design verification strategies, and design transfers for testing readiness, which includes incoming and release tests for components and combination products
• This position also supports other critical activities such as drug product and combination product final assembly processes validations
• All activities will require collaboration with cross-functional teams both within and outside of Device Development & Technology
• The incumbent must be able to work well with employees at all levels to effectively engage and coordinate the implementation/ readiness and execution of design verification tests and methodologies in support of key development activities

Additionally, this position will require applying knowledge in drug and device product development, such as manufacturing process development and validation, design control, risk management, material and molding, design validation to create and execute design verification strategies that successfully supports the clinical instruction(s) and commercial market approval(s) of combination products

• Lead, set direction, align with key stakeholders, and successfully execute, design verification strategies for assigned drug-device combination product program(s) for successful clinical introduction(s) and commercial market(s) approval(s)
• Define design input(s)/ output(s) and lead associated combination product design verification plan, protocol(s), and report(s) that demonstrate design output(s) meet design input(s)
• Lead establishment of test methodologies, including method development and validation, internally or externally, per design verification strategy
• Lead strategy and execution of accelerated and real time aging studies including bridging studies at the device component/ subassembly/ in-process material and combination product level
• Lead stablishing test methodologies/ testing readiness and execution in support of critical activities such as stability studies, drug product filling process validation, combination product final assembly process validation, shipping studies, etc
• Support establishment of incoming and release tests at the component and combination product level with key functional areas
• Oversee design verification activities performed by external partners
• Proactively anticipate and resolve project obstacles and effectively communicate complex product technical challenges, design verification strategy, timelines, milestones, and risks within our Company and with external partners
• Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership
• Lead/ Support clinical supplies production with respect to device component and combination product testing
• Maintain a high level of engagement with cross-functional team members to effectively implement and successfully execute against design verification strategies
• Stay current with new device technologies, relevant worldwide regulations, standards, and effectively share this knowledge with others
• Enhance our Company’s professional image and competitive advantage through publications, presentations, patents, and professional activities
• 21 CFR Part 4
• FDA Guidance for Industry, Container Closure Systems for Packaging Human Drugs and Biologics

This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely

B.S. in Mechanical Engineering (or an equivalent field) + 8 years of combination product development experience; M.S. in Mechanical Engineering (or an equivalent field) + 5 years of combination product development experience; or a Ph.D. in Mechanical Engineering (or an equivalent field) + 3 years of combination product development experience

• Comprehensive understanding of drug product development in addition to device development expertise
• Strong familiarity with regulatory landscape associated with drug delivery combination product and design verification requirements
• Proven track record of applying analytical skills in product test method design, development, and validation
• Working knowledge of analytical test method technology transfer process
• Skilled in laboratory good documentation practices and electronic documentation systems
• Self-motivated with ability to work independently
• Proven ability to lead teams of diverse skill sets and backgrounds
• Strong interpersonal skills and a strategic thinker; able to influence without formal authority; ability to influence and present ideas to senior leadership
• Willing to travel
• Fluency with industry-related guidance & standards:
• EU Medical Device Regulation
• ISO 14971
• ISO 11608
• ISO 11040
• ISO 10993
• ISO 23908
• ISO 80369
• ISTA 3A/B
• ASTM D4169

ASTM F1980

• Leadership experience of combination product design verification programs and leading activities (e.g., strategy/ plan, protocol(s), report(s), test method development/validation, etc.) requiring cross-disciplinary project teams

Leadership experience with comprehensive knowledge of various aspects of device development and their interdependencies with design verification, including but not limited to, design controls, risk management, materials & molding, process development and validation, secondary packaging development & qualification, and design validation

• Strong working knowledge of standards relevant to device components and combination products, including ISO 11608, ISO 11040, ISO 80369, as well as performance tests related to container closure integrity and dose accuracy, among others
• Excellent communication, prioritization, presentation, negotiation, project management, and organizational skills

Combination Products, Combination Products, Cross-Team Collaboration, Cultural Diversity, Customer Experience Design, Design Controls, Design Failure Mode and Effect Analysis (DFMEA), Design Verification Testing, Device Development, Diversity Awareness, Drug Development, Human Factor Engineering, Manufacturing Processes, Mechanical Engineering, Mechanical Testing, Medical Device Quality Systems, Microscopies, Negotiation, Optical Microscopy, Product Commercialization, Production Process Development, Project Management, Prototyping, Quality Management Systems (QMS), Self Motivation {+ 3 more}

$139,600.00 - $219,700.00 An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable
• We offer a comprehensive package of benefits

Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days