Associate Director, DrugDevice 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:

• Bachelors or Masters 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:

Preferred Skills:

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The salary range for this role is

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 employees 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 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.

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