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

MSD•Rahway, NJ

1d•$142,400 - $224,100

About The Position

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.

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.

Nice To Haves

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)

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.