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

About the role

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

Responsibilities

• Lead a Center of Excellence (CoE) for developing and validating platform and innovative device/CP functional test methods 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 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 functional testing methods meet regulatory requirements, industry standards, and internal Quality Management System (QMS) compliance.
• Focus on talent retention, training/upskilling, and recruiting top talent to deliver on pipeline and innovation projects.
• Ensure training, safety, and compliance requirements are met, with clear roles and responsibilities.
• Provide employee development and growth opportunities.

Requirements

• Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a 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 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 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.

Skills

• Required: Analytical Chemistry, Biocompatibility, Biomedical Engineering, Chemical Biology, Computer-Aided Design (CAD), GMP Compliance, Process Engineering, Product Development, Product Risk Management, Project Management, Quality Control Management, Quality Management, Risk Management, Statistical Analysis, Technical Writing, Verification and Validation (V&V).
• Preferred: Experience with current employees or contingent workers in similar roles.

Pay

The salary range for this role is $142,400.00 - $224,100.00. An employee’s position within the salary range will be based on factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

We offer a comprehensive package of benefits, including:

• Medical, dental, vision, 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 https://jobs.merck.com/us/en/compensation-and-benefits.