Senior Scientist, Drug/Device Combo Products
About The Position
Our Company's Combination Product Characterization and Verification (CPCV) Team is seeking a hands-on device characterization and design focused scientist. This position will be responsible for technical interrogation of the various drug delivery device technology platforms supporting our company’s pipeline to identify risks (i.e. when/how will the device fail?) and opportunities for improvement. In this role, the successful candidate will leverage a broad range of cutting-edge analytical instruments and methodologies, including in silico modeling, to develop a fundamental understanding of device material and functional properties, with a focus on pre-filled syringe and auto injector combination product development. The successful candidate must have effective cross functional collaboration skills, demonstrated excellent scientific leadership, and superior written and oral communications abilities.
Requirements
- B.S., M.S or Ph.D. in Mechanical Engineering, Material Science or equivalent field.
- A minimum of a Ph.D., M.S. plus 4 years, or B.S. plus 6 years of design, engineering, and testing/test method development experience.
- Solid testing and troubleshooting skills able to work independently in a laboratory setting.
- Strong background in optical imaging and mechanical testing, including advanced imaging techniques, tensile and compression testing, surface characterization, X-ray computed tomography, rheometry, and microscopy.
- Excellent collaboration, ideation, and prototyping skills, including facilitating design brainstorming sessions, developing proof of concepts, working prototypes and conducting functional testing.
- Experience in 3D CAD (e.g. Solidworks), geometric tolerancing and stack-up analysis.
- Fluency in Design Failure Modes and Effect Analysis (FMEA, DFMEA).
- Development experience in risk-oriented, regulated environments.
- Development project leadership with a proven track record collaborating with and managing external vendors/manufacturers.
Nice To Haves
- Experience with medical device development with understanding of Design Controls (21 CFR 820.30).
- Familiarity with the following standards: Quality Management – ISO 13485, Risk Management – ISO 14971, EU MDR, Medical Electrical Equipment – EN 60601, Medical Device Software Standard – IEC 62304, ISO 11608 Needle-based injection system for medical use.
- Additional familiarity/experience with the following industry related knowledge is a plus: 21 CFR Part 4, 21 CFR 211, FDA Guidance for Industry, Container Closure Systems for Packaging Human Drugs & Biologics, ISO 13485, ISO 14971, ISO 11040, ISO 10993.
Responsibilities
- Technical interrogation of drug delivery device technology platforms to identify risks and opportunities for improvement.
- Leverage analytical instruments and methodologies, including in silico modeling, to understand device material and functional properties.
- Focus on pre-filled syringe and auto injector combination product development.
- Collaborate effectively with cross-functional teams.
- Demonstrate scientific leadership.
- Communicate effectively in written and oral formats.
- Liaise closely with partner functions including QA, Analytical Sciences, and CROs to support project timelines.
- Communicate complex mechanical engineering information in layman’s terms to facilitate cross-functional understanding.
- Manage external vendors/manufacturers.
Benefits
- Medical, dental, vision healthcare and other insurance benefits (for employee and family)
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
- Annual bonus
- Long-term incentive
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
