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

Job Description

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 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.

-

-

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
• USP
• 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:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

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.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement•

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. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.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. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The salary range for this role is
$142,400.00 - $224,100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. 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. More information about benefits is available at .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: -We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: -We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully-
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. -No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.-

Employee Status:
Regular

Relocation:
Domestic

VISA Sponsorship:
Yes

Travel Requirements:
No Travel Required

Flexible Work Arrangements:
Not Applicable

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
03/13/2026
*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R384123