Senior Scientist

Overview

Position: Formulation Design Lead / Senior Scientist – Product Development
Location: Raritan, NJ

We are seeking an experienced Formulation Design Lead / Senior Scientist to drive formulation and biomaterials development from early concept through prototyping, validation, and clinical translation. This role partners cross-functionally with suppliers, R&D, Quality, Manufacturing, and Clinical teams to deliver robust, scalable product designs aligned to pre-clinical and clinical outcomes.

• Lead formulation design efforts from concept through prototyping, design reviews, and validation.
• Collaborate with external suppliers and internal partners to develop innovative products.
• Drive product characterization to establish strong technical understanding and links to pre-clinical/clinical performance.
• Lead raw material development and iteration with suppliers to define the product design window.
• Develop and execute Learning Plans to accelerate development and de-risk designs.
• Participate in cross-functional design reviews across modeling, lab, pilot, and manufacturing scales.
• Support clinical procedures and translate learnings into viable product prototypes.
• Contribute to product creation and scale-up activities across R&D and manufacturing environments.

• Proven experience launching new products and formulations to market.
• Strong background in biomaterials and material development (highly preferred).
• Experience in medical device product design
  ; combination products (drug/device) experience strongly preferred.
• Familiarity with PMA pathways is a plus.
• Demonstrated problem-solving skills using analytical technologies.
• Experience with Design of Experiments (DOE) methodologies.
• Experience developing protocols and writing technical and validation reports.
• Working knowledge of basic statistics
  .
• Experience with in vitro and ex vivo methods for prototype and product characterization.
• Experience developing and validating biochemical test methods for finished products and raw materials.
• Excellent communication, collaboration, and influencing skills.
• Proven ability to deliver results in ambiguous, fast-paced environments.
• Experience leading or managing self-directed project teams
  .
• Willingness to travel up to 20% (domestic and international).

• Advanced degree (PhD strongly preferred) in:
• Chemical Engineering
• Pharmaceutical Sciences
• Polymer Science / Polymer Engineering

• Education: Chemical Engineering or any advanced degree in Chemistry / Chemical Sciences.
• Experience: 10+ years in medical technology formulation development
  .
• Must Have: Strong biomaterials development experience (preferably gelatin-based systems
  ).
• Product Lifecycle: Proven experience taking products from proof-of-concept through clinical-stage development
  .
• Nice to Have:
  
  Experience with
  Class III medical devices
  .