Associate Principal Scientist – Device Analytical Lead in Analytical Research & Development
| Company | Inventing for Life |
|---|---|
| Location | North Wales, PA, USA, Linden, NJ, USA, Dublin, Ireland |
| Salary | $139600 – $219700 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Mid Level, Senior |
Requirements
- A Ph.D. with a minimum of 3 years of relevant work experience or a Master’s degree with a minimum of 6 years of relevant work experience or a Bachelor’s degree with a minimum of 8 years of relevant work experience
- Proven track record of successful project management, encompassing resource management, risk assessment and mitigation strategies, as well as the ability to effectively track, support and communicate the timely delivery of project milestones
Responsibilities
- Take the lead in overseeing device GMP analytical activities for multiple MDCP programs
- Execute AR&D’s device strategy and optimization of the operating model to deliver results aligned with enterprise goals
- Develop an incoming and release testing strategy, lead siting discussions for clinical and commercial testing, and develop specifications
- Ensure adherence to timelines by effectively managing all analytical activities to support on time release of clinical supplies
- Work with the validation team on method validation and transfer activities at clinical GMP labs and commercial QC labs
- Partner with cross-functional device, analytical, regulatory and quality functions within our divisions to manage End-to-End MDCP testing activities including internal and external device testing activities
- Support regulatory filings through documentation authoring and reviews (i.e. INDs, BLAs, etc.)
Preferred Qualifications
- In-depth knowledge of medical device CMC landscape including knowledge of ISO standards, EU MDR, GMP, ICH and relevant HA guidelines
- Experience with medical device development with understanding of Design Controls (21 CFR 820.30)
- Extensive experience with a wide variety of device analytical methods, including but not limited to, device functionality testing and container closure integrity (CCI) testing
- Outstanding communication, critical thinking, and leadership skills
- Proficient in navigating fast-paced and dynamic work environments
- Demonstrated track record of working across networks, both internally and externally, to deliver exceptional results aligned with program timelines