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Merck · 2 days ago

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

Rahway, NJ

Full-time

Hybrid

Lead/Staff, Director/Executive

$140K/yr - $220K/yr

5+ years exp

Merck is a global healthcare company focused on the development and commercialization of innovative combination products. The Associate Principal Scientist will lead the design verification testing strategies for these products, ensuring effective delivery and compliance with regulatory standards.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

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

Qualification

Combination Product DevelopmentDesign Verification TestingDevice DevelopmentRegulatory KnowledgeMechanical EngineeringManufacturing ProcessesAnalytical SkillsCross-Team CollaborationProject ManagementInterpersonal SkillsSelf MotivationCommunication SkillsNegotiation SkillsOrganizational Skills

Required

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 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

Excellent communication, prioritization, presentation, negotiation, project management, and organizational skills

Willing to travel

Preferred

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