Formulation Lead
Fusion Life Sciences Technologies LLC
Raritan, NJ
JOB DETAILS
JOB TYPE
Full-time, Employee
SKILLS
Analysis Skills, Biochemistry, Biotech and Pharmaceutical, Chemical Engineering, Chemistry, Clinical Outcomes, Clinical Support, Clinical Validation, Communication Skills, Cross-Functional, Drug Development, Drug Products, Experiment Design, Leadership, Manufacturing, Medical Equipment, Medical Products, Model Review, Polymers, Pre-Clinical, Problem Solving Skills, Product Design, Product Development, Product Lifecycle, Product/Service Launch, Proof of Concept, Prototyping, Quality Assurance Methodology, Research & Development (R&D), Risk, Statistics, Team Player, Technical Writing, Technical/Engineering Design, United States Department of Energy (DOE), Vendor/Supplier Planning, Willing to Travel
LOCATION
Raritan, NJ
POSTED
9 days ago
Position: Formulation Design Lead / Senior Scientist – Product Development
Location: Raritan, NJ(Onsite)
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
- Bachelor’s degree required.
- Advanced degree (PhD strongly preferred) in:
- Chemistry
- 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.
Engagement Model: C2H role – 8 months contract, with intent to convert to full-time based on performance.
About the Company
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