Associate Director, Drug/Device Combination Products - Method Development & Testing

Job Description

The Associate Director of Method Development & Testing is responsible for leading a Center of Excellence (CoE) focused on developing and validating platform and innovative device/CP functional test methods with high technical rigor to support development, IND-enabling stability, commercial stability, and Design Verification. This role involves leading the method tech transfer strategy and execution to internal and external GMP testing nodes in support of clinical and PPQ supplies. Additionally, the Associate Director leads, manages, and develops a team responsible for providing routine functional testing support for Device Characterization (DC) and Design Verification (DV) deliverables across development to commercialization.

Responsibilities:

• Lead a Center of Excellence (CoE) focused on developing and validating platform and innovative device/CP functional test methods with high technical rigor to support development, IND-enabling stability, commercial stability (PSS), and Design Verification (DV).
• Lead method tech transfer strategy and execution to internal and external GMP testing nodes in support of clinical and PPQ supplies.
• Lead, manage, and develop a team responsible for providing routine functional test method development and testing support for Device Characterization (DC) and Design Verification (DV) deliverables across development to commercialization.
• Collaborate with Analytical Research & Development (AR&D), Design Controls & Risk Management (DCRM), Quality, Regulatory, and Quality Control (QC) facilities to ensure that functional testing methods meet regulatory requirements, industry standards, and internal Quality Management System (QMS) compliance.
• Talent retention, training/upskilling, and recruiting of top talent as needed to deliver on pipeline and innovation projects.
• Ensure training, safety, and compliance requirements are met and roles and responsibilities are clearly understood and followed.
• Employee development and growth opportunities.

Qualifications:

• Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related field. Advanced degree (PhD) preferred.
• 8+ years of experience in method development, validation, and testing within the pharmaceutical, medical device, or combination product industry.
• Demonstrated leadership experience in leading and managing teams, preferably in a regulated industry.
• Extensive knowledge of method development, validation, and transfer, with an understanding of regulatory requirements and industry best practices.
• Experience in collaborating with CMC cross-functional teams including Drug Substance, Drug Product, Analytical, Design Controls & Risk Management, Quality, Regulatory, and QC facilities.
• Strong project management skills and the ability to prioritize and manage multiple projects and resources effectively.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders.

Required Skills:
Analytical Chemistry, Biocompatibility, Biomedical Engineering, Chemical Biology, Computer-Aided Design (CAD), GMP Compliance, Process Engineering, Product Development, Product Risk Management, Project Management, Project Management Support, Quality Control Management, Quality Management, Risk Management, Statistical Analysis, Technical Writing, Verification and Validation (V&V)

Preferred Skills:

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US and Puerto Rico Residents Only:

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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:

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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.

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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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:
08/8/2026
*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: R410043