Associate Principal Scientist, Combination Product Design Verification (Associate Director Equivalent) Full-time

Associate Principal Scientist

Are you enthusiastic and driven to create and lead execution of design verification testing strategies for innovative combination products?

Join our company's Device Product & Process Development (DPPD) Team, which focuses on the design, development, and commercialization of novel biologic/drug/vaccine-device combination products for safe and effective delivery to their intended sites of action. The DPPD Team oversees the development of the device constituent within our pipeline of combination products, spanning various therapeutic areas and routes of administration, including inhalation, implantation, and injection.

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.

Principal Responsibilities

• 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 establishing 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.

Qualifications

Requirements:

• 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.

• 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.
• 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.
• 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.
• 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 many 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.
• Excellent communication, prioritization, presentation, negotiation, project management, and organizational skills.
• Willing to travel

Preferred experiences include:

• Combination product drug delivery device components – plastic, metal, glass, elastomeric materials, etc. – fracture, stress-strain response, friction, hardness, surface roughness, surface energy quantification.
• Combination product sub-assemblies (including electro-mechanical) – system tear down analysis, gear ratio optimization, weakest link component identification and optimization, etc.
• Material characterization and failure mode analysis and integration with combination product risk management.
• Stress-strain testing of different materials under different environmental conditions, i.e., temperature, humidity.
• Eagerness to identify lab capability gaps, drive procurement of new equipment, and quickly upskill (also train others) on operation.
• Experience with analytical or numerical simulation.
• Excellent collaboration and ideation skills, including facilitating brainstorming sessions, developing proof of concepts, and generating feasibility data.

• Strong familiarity with compression/tensile testing (Instron, Zwick, Texture Analyzer), rheology (TA Instrument), metrology/non-destructive inspection (XRCT [Zeiss], Optical microscopy [Keyence], high speed imaging)
• Experience in 3D CAD (Solidworks) and rapid manufacturing techniques (machining, 3D printing) for fixture development and device redesign efforts.

Fluency with industry-related guidance & standards:

• 21 CFR Part 4
• 21 CFR 820
• 21 CFR 210/ 211
• EU Medical Device Regulation
• USP <1>
• USP <697>
• FDA Guidance for Industry, Container Closure Systems for Packaging Human Drugs and Biologics
• ISO 13485
• ISO 14971
• ISO 11608
• ISO 11040
• ISO 10993
• ISO 23908
• ISO 80369
• ISTA 3A/B
• ASTM F1886
• ASTM D4169
• ASTM F1980

Required Skills:

Preferred Skills:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds.

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