Formulation Scientist (Medical Device)
Fusion Life Sciences Technologies LLC
Position: Formulation Design Lead / Senior Scientist – Product Development Location: Raritan NJ Role Overview 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. Key Responsibilities 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. Qualifications & Experience 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). Education Advanced degree (PhD strongly preferred) in: Chemical Engineering Pharmaceutical Sciences Polymer Science / Polymer Engineering Additional Requirements / Screening Criteria 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 . #J-18808-Ljbffr Fusion Life Sciences Technologies LLC
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