Vice President of Research & Development

Role details

Vice President of Research & Development

Location: On Site

Department: Research & Development

Reports To: Chief Executive Officer (CEO)

Position Summary

The Vice President of R&D leads the strategic direction, formulation chemistry, and commercialization of advanced delivery systems, specializing in Oral Dissolving Films (ODF) for dietary supplements, bioactive peptides, and drug API. This executive drives novel product development from bench-scale formulation through full-scale roll-to-roll manufacturing. The ideal candidate will combine expertise in polymer matrix design, API stability, and buccal/sublingual absorption pathways while ensuring strict adherence to FDA cGMP (21 CFR Part 111), DSHEA, and international regulatory frameworks.

Key Responsibilities

• Strategic Product Innovation: Lead the product development pipeline for oral dissolving films, leveraging proprietary polymer matrices to deliver dietary supplements, botanical extracts, and therapeutic efficiently.
• Peptide Formulation & Stability: Overcome complex technical challenges specific to peptide delivery in film formats, including maintaining structural integrity, preventing enzymatic degradation, optimizing buccal bioavailability, and achieving target disintegration times.
• Process Engineering & Scale-Up: Work directly with our process engineers on technology transfer from lab-scale casting to continuous roll-to-roll drying, slitting, and primary packaging operations; optimize viscosity, drying profiles, tensile strength, and mass uniformity across production runs.
• Organoleptic & Matrix Optimization: Resolve taste-masking issues inherent to active and concentrated nutrients while optimizing strip mechanical properties (flexibility, dissolution rate, moisture content).
• Regulatory & Quality Compliance: Oversee formulation compliance under FDA 21 CFR Part 111 (cGMP), FTC guidelines, and DSHEA regulations, ensuring all active ingredients, excipients, and label claims meet global standards.
• Intellectual Property & Clinical Validation: Drive IP creation for novel film platforms, stability enhancement methods, and API loading techniques; design pilot kinetic and mucosal permeability studies.
• Stability Testing Infrastructure: Establishing real-time and accelerated stability programs specific to sensitive peptides and film strip shelf-lives.
• Competitive Intelligence: Benchmarking competitor patents and alternative delivery systems (liposomes, sprays, micro-encapsulation) to keep the company's film tech ahead of the curve.
• Pipeline & Portfolio Prioritization: Deciding which project concepts get funded, paused, or killed based on business ROI, manufacturing throughput, and market demand (Resource Allocation).
• Sales & Client Engagement: Participating in pitch meetings with major brand partners/clients to translate complex film/peptide tech into commercial sales pitches.
• Lab Testing: Determine scale of our internal testing vs. Utilizing 3rd party testing labs, identify tests that should be brought in internally and develop SOPs and standards for testing requirements for all raw materials and finished products.

Required Qualifications

• Education: Ph.D. or Master’s degree in Polymer Chemistry, Pharmaceutical Sciences, Chemical Engineering, Biochemistry, or a related scientific discipline.
• Experience: 7–10+ years of R&D leadership experience, ideally in thin-film technologies (ODF/transdermal), oral delivery systems, or novel nutraceutical dosage forms.
• Chemistry Knowledge: Solid understanding of API degradation pathways, peptide-polymer interactions, mucosal absorption enhancers, and analytical methods (HPLC, LC-MS) for peptide quantification.
• Regulatory Mastery: Deep operational knowledge of FDA 21 CFR Part 111 (cGMP for Dietary Supplements), DSHEA compliance, and raw material qualification for novel actives.
• Leadership: Proven track record of scaling novel drug or supplement delivery platforms from concept to commercial execution in a CDMO/CMO or proprietary manufacturing environment.

Preferred Competencies

• Direct experience with sublingual and buccal transmucosal delivery mechanisms.
• Deep network of specialized peptide synthesis partners, specialty polymer vendors, and contract testing facilities.
• Strong business acumen with the ability to articulate technical innovation to investors, executive leadership, and commercial partners.
• Film Casting Expertise: Hands-on technical mastery of solvent-casting techniques, film-forming polymers (e.g., HPMC, pullulan, alginates), plasticizer optimization, and continuous coating equipment.