Senior Director, Formulation Sciences
Posted on Apr 5, 2021 by Pharmacyclics
We are seeking a highly motivated and experienced leader with a proven track record of leadership to serve as the Senior Director of Formulations Sciences reporting to the Vice President of Drug Product Development. This position will be an integral part of the product development teams and will have strong collaboration with Pharmaceutics, Process Engineering Sciences, Analytical Research and Development, the Drug Product Pilot Plants, and the Operations Commercial Manufacturing functions. The Senior Director will lead an organization and will have a group of approximately 20 scientists.
- Ensures appropriate systems and work processes are in place to efficiently develop drug product technology based on sound science.
- Develops global strategies appropriate to the functional area for which the incumbent is responsible. Develops implementation plans in collaboration with local leadership teams to ensure global strategies are effective.
- Provides resources to support product development teams
- Establishes, and manages within, timelines and functional budget
- Delivers CMC regulatory documentation that supports CMC packages suitable for global registration, approval, and successful product launches.
- Ensures application of sound science and technology using a phase appropriate level of quality, and ensures compliance with global regulatory, quality, environmental, health and safety regulations.
- Manages DPD resource to ensure appropriate skill base and deployment to meet the needs of the programs
- Ensures staff receive appropriate technical, professional and compliance training and development to meet the needs of DPD.
- Ensure development of technologies that drive formulation excellence and scientific innovation that improve the future capabilities and productivity of the greater organization
- Collaborate with other functions within to align a broad range of strategies that directly support drug discovery and development programs; these include but are not limited to other areas in Development Sciences, Drug Product Development, Regulatory Affairs and Commercial Manufacturing Operations
- Sources and identifies emerging scientific trends from multiple internal and external sources and assess relevance. Integrates trends into functional short-term objectives. Advances cross-discipline technology and direction through generation of data.
- Assures compliance with safety, quality and regulatory policies and government regulations
- Generate new scientific proposals and lead those efforts. Anticipate and critically evaluate scientific or regulatory advances or competitive threats and respond with appropriate new strategies.
- Recognized and sought out as an expert in his/her discipline within the company and possibly externally.
- Ph.D. Degree and 14+ years of relevant academic, pharmaceutical industry, or other relevant experience;
- Or Master's Degree and 20+ years of relevant academic, pharmaceutical industry, or other relevant experience;
- Or Bachelor's Degree and 22+ years of relevant academic, pharmaceutical industry, or other relevant experience.
- Ph.D. preferred.
- Experience in research and/or development environment.
- Demonstrated leadership of technical teams and effective cross-functional communication
- Proven ability to solve critical business and scientific problems
- Extensive experience in drug product formulation development and filing
- Familiarity with broad range of dosage forms for delivery of complex formulations
- Strong technical background in oral drug product formulation development and characterization
- Understanding of cGMP, regulatory and process safety requirement
Key Leadership Competencies
- Builds a strong organization, develops team members, drives technical excellence, and inspires continuous improvement
- Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance
- Learns fast, grasps the "essence" and can change course quickly where indicated.
- Raises the bar and is never satisfied with the status quo
- Creates a learning environment, open to suggestions and experimentation for improvement
- Embraces the ideas of others, nurtures innovation and manages innovation to reality