Senior Director of Device Development
4 weeks ago
Job Summary
The Associate Director of Device and Combination Product Testing will lead a Center of Excellence 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.
Responsibilities:
- Lead a Center of Excellence 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.
- 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 testing support for Device Characterization and Design Verification deliverables across development to commercialization.
- Collaborate with Analytical Research & Development, Design Controls & Risk Management, Quality, Regulatory, and Quality Control facilities to ensure that functional testing methods meet regulatory requirements, industry standards, and internal Quality Management System 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.
Qualifications:
- Bachelor's or Master's degree in Chemistry, Analytical Chemistry, Biochemistry, 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 cross-functional teams including AR&D, DCRM, Quality, Regulatory, and QC facilities.
- Strong project management skills and the ability to prioritize and effectively manage a multitude of projects simultaneously.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders.
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