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VP of R&D
4 months ago
RESPONSIBILITIES
- Developing innovative scientific and production strategies to support business expansion and explore new opportunities.
- Overseeing the development of chemical synthesis pathways or other methods for producing compounds of interest, aligned with our business strategy.
- Providing strategic leadership to develop and implement a comprehensive development strategy for the cannabis and psychedelic portfolio, focusing on achieving key milestones.
- Collaborating with management, quality assurance, manufacturing, and other related functions on the development and future deployment of new molecules and formulations.
- Working closely with customers and partners to align goals and achieve mutual satisfaction and benefits.
- Leading the design and execution of Quality-by-Design (QbD) product development studies and develop scalable manufacturing processes for parenteral drugs.
- Managing formulation development for new products, ensuring optimized formulations for performance and stability, studying material compatibility, and evaluating sterilization options.
- Enhancing market acceptance of the company’s products.
- Maintaining effective communication with internal and external stakeholders, including clients, investors, partners, and regulatory bodies.
- Presenting development updates, strategic insights, and risk assessments to the executive team and board of directors.
- Developing and managing the development budget, ensuring optimal allocation of resources to achieve project milestones and strategic objectives.
- Demonstrating strong leadership skills through the supervision, coaching, and mentoring of team members.
- Developing scalable manufacturing processes in line with cGMP and regulatory requirements.
- Supporting troubleshooting of existing commercial processes as needed.
- Providing data and support for the creation, submission, and approval of regulatory documents, including Drug Master Files, INDs, NDAs, and others.
QUALIFICATIONS
- Minimum 15+ years of experience and/or knowledge in organic synthesis, process development, and enabling technologies.
- Relevant industry experience in pharmaceutical/biotechnology small molecule development and/or business development.
- Experience in contract manufacturing (API and Drug Product), drug delivery, and contract research.
- Proven track record of successful leadership in API, formulation, and product development, preferably within the cannabis/psychedelic area.
- Understanding of the overall drug development process, regulatory guidelines, and CMC strategy in the US, with global experience being a plus.
- Ability to effectively interact with and influence suppliers/vendors, regulators, global partners, industry executives, and trade organizations.
- Demonstrated managerial experience in leading a team of scientists in R&D, formulation, and quality.
- Strong analytical problem-solving skills, with a history of leading and motivating teams to develop innovative and sustainable solutions.
- Preferred experience with tradeshows/conferences, established industry connections, and technical writing.
- Ability to prioritize and manage multiple complex situations, make strong decisions, and work through ambiguity and uncertainty.
- Excellent presentation, communication, and interpersonal skills.
EDUCATION
- MD, PhD, or equivalent degree in a life sciences or medical discipline
