Vice President / Senior Director, Research & Development

About the Company

The Vice President / Senior Director of Research & Development (R&D) will lead the strategic direction, development, and execution of the organization’s formulation and product development initiatives across a diverse portfolio of dosage forms, including liquid, solid oral, capsules, troches, gummies, and semi-solids. This role requires a highly experienced pharmaceutical development leader with a proven track record of building R&D capabilities from the ground up, developing innovative formulations, and leading high-performing technical teams. The ideal candidate brings deep expertise in pharmaceutical formulation (beyond 503A compounding), with the ability to translate scientific innovation into scalable, commercially viable products.

About the Role

The Vice President / Senior Director of Research & Development (R&D) will lead the strategic direction, development, and execution of the organization’s formulation and product development initiatives.

Responsibilities

R&D Strategy & Leadership

• Define and execute the R&D strategy aligned with business growth, pipeline development, and market opportunities
• Build and lead a high-performing R&D organization, including formulation scientists, analytical teams, and technical support staff
• Establish short- and long-term product development roadmaps across multiple therapeutic and dosage form platforms
• Serve as a key member of the executive leadership team, contributing to strategic planning and innovation initiatives

Formulation & Product Development

• Lead the development of complex formulations across:
• Liquid (oral and topical)
• Solid oral dosage forms (tablets, capsules)
• Troches/lozenges
• Gummies and novel delivery systems
• Semi-solids (creams, gels, ointments)
• Apply deep pharmaceutical formulation expertise to ensure stability, bioavailability, scalability, and patient usability
• Drive innovation in multi-API and differentiated formulations

Lab Build-Out & Infrastructure

• Lead the design, build-out, and operationalization of R&D laboratory capabilities from the ground up
• Establish equipment selection, workflows, and best practices for formulation and analytical development
• Implement systems and processes to support efficient, compliant, and scalable R&D operations

Pharmaceutical Development & Scale-Up

• Ensure all formulations are developed with a clear path to scale, manufacturing feasibility, and commercial viability
• Collaborate with Operations and Manufacturing teams on tech transfer, process optimization, and scale-up activities
• Apply industry-standard development principles (QbD, DoE, etc.) to formulation and process development

Regulatory & Compliance Alignment

• Ensure R&D activities align with applicable regulatory expectations, including FDA guidance and relevant USP standards
• Support regulatory strategy, documentation, and responses as needed
• Maintain high standards of scientific rigor, documentation, and data integrity

Team Leadership & Development

• Recruit, develop, and mentor a multidisciplinary R&D team
• Foster a culture of innovation, accountability, and scientific excellence
• Establish performance metrics and development plans for team members

Cross-Functional Collaboration

• Partner with Commercial, Operations, Quality, and Regulatory teams to align product development with market needs and compliance requirements
• Provide technical leadership in evaluating new product opportunities, partnerships, and technologies

Qualifications

Experience

• 20 years of experience in pharmaceutical R&D, with significant experience in formulation development across multiple dosage forms
• Demonstrated experience formulating within the pharmaceutical industry (not solely 503A compounding)
• Proven track record of building or significantly scaling an R&D function or laboratory from the ground up
• Extensive experience leading and managing R&D teams, including scientists and technical staff
• Experience with tech transfer, scale-up, and commercialization of formulations

Technical Expertise

• Deep expertise in formulation science across liquids, solid oral dosage forms, capsules, troches, gummies, and semi-solids
• Strong understanding of bioavailability, stability, excipient compatibility, and delivery systems
• Experience with complex and multi-API formulations preferred
• Familiarity with pharmaceutical development best practices (e.g., QbD, DoE)

Leadership & Skills

• Strong executive presence with the ability to influence at all levels of the organization
• Strategic thinker with strong execution capabilities
• Proven ability to lead cross-functional teams and drive results in a fast-paced environment
• Excellent problem-solving, decision-making, and communication skills

Education

• PhD, MS, or equivalent advanced degree in Pharmaceutics, Pharmaceutical Sciences, Chemistry, or a related field preferred
• Bachelor’s degree required

Key Attributes

• Builder mindset with hands-on leadership capability
• Innovative and forward-thinking approach to formulation development
• Strong commercial awareness and ability to translate science into business value
• High level of accountability, ownership, and execution