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Development Scientist

2 months ago

Silver Spring, United States Elutia Full time

Position Overview:


The Development Scientist at Elutia plays a pivotal role in pioneering and developing biological-based medical devices, specializing in drug/device combination products at the forefront of the industry. This role encompasses overseeing the entire development process, from initial concept through to commercialization. The Development Scientist leads in-depth characterization and formulation of biological matrices and polymer-based drug delivery technologies for extended release. They manage prototype and pilot production, execute test methods, and collaborate across teams to propel Elutia's product pipeline forward with a sense of urgency. Integral to their responsibilities is ensuring seamless project development, securing rapid regulatory approvals, and facilitating tech transfer. Additionally, the Development Scientist actively contributes to the intellectual property portfolio and supports lifecycle management.


The successful candidate will work onsite at the Company’s Silver Spring, MD office.


Essential Duties & Responsibilities:


Designing and characterizing biological matrices and drug/device combination products according to industry standards.

Developing drug coating, polymer and alternative drug delivery methods for sustained or extended release products.

Developing and executing novel test methods to support discovery and development.

Driving prototype development and pilot production of new products in collaboration with Manufacturing and Quality Control Systems.

Applying critical thinking skills to product development and design, troubleshooting technical issues in the lab.

Establishing testing plans and ensuring timely completion of technical deliverables.

Leading project development and overseeing tech transfer to manufacturing for clinical and commercial use.

Contributing to the intellectual property portfolio through innovative solutions.

Supporting a successful and efficient FDA and OUS regulatory approval process.

Maintaining accurate and timely records of development activities as per written procedures.

Collaborating across multiple functions, including Marketing, Regulatory Affairs, Quality, and Clinical Operations.


Education & Experience:


MS or PhD in Chemistry, Pharmaceutical Sciences, or related field from an accredited college or university, or equivalent combination of education and work experience. Relevant experience may be considered in lieu of an advanced degree.

3-5 years’ experience within Biotech or Pharm industries.

Proven experience with drug development and the regulatory approval process, including FDA submissions such as De Novo, PMA, and combination product pathways.

Preferential background in test method and analytical method development and validation.

Preferred experience in the development of drug-device combination products.

Demonstrated experience exemplifying our CRU values: contagiously confident, ridiculously relentless, unanimously united

Demonstrated success in a fast-paced, entrepreneurial environment.

Exceptional written, communication, and presentation skills.