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

About the role

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). 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.
• Focus on 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.
• Provide employee development and growth opportunities.

Requirements

• 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.

Skills

• Required: 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: Experience with current employees or contingent workers in relevant fields.

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 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.

Benefits

We offer a comprehensive package of benefits including:

• 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 Merck Compensation and Benefits.