Senior Director Product Development

Senior Director, Formulation & Product Development

I am working with a leading CDMO provider of comprehensive API sourcing and drug product contract development and manufacturing solutions to the pharmaceutical industry who are looking for an experienced Product Development Director in the Colorado area.

RESPONSIBILITIES:

• Directs & develops formulation design, characterization, and development activities associated with the solids, liquids and semi solid ANDAs and NDAs portfolio.
• Leads a team of pharmaceutical scientists and works with other internal and external partners.
• Provides oversight and direction for individuals and teams responsible for: creating and executing formulation development, early process development; developing and documenting the knowledge base needed for regulatory filings; and managing projects.
• Provides input to the development of program strategy, budgets, timelines, and formulation development plans.
• Creates, promotes, and improves formulation technical capabilities and related workflows for the formulation development group and with associated partners.
• Identifies and develops tools and methods for designing and developing formulations; develops and applies tools for material and process characterization and selection;
• Acts as CMC reviewer and subject matter expert for all drug product regulatory submissions.
• Acts as a subject matter expert during FDA interactions.
• Develops and prepares technical documentation for specific projects as assigned.
• Builds and maintains strong working relationships with relevant internal and external partner groups (Project Leadership, Business Development, Regulatory, and Quality ensuring that activities are managed collaboratively, efficiently, and effectively.
• Develops appropriately proactive resource plans and utilizes staff and other resources effectively to meet area/partners’ needs.
• Uses appropriate tools to regularly review measure, modify, and adjust plans and to monitor the efficiency, effectiveness and balance of resources according to evolving business needs and environment.
• Models good decision making practices and assesses and rewards behaviours consistent with good decision making practices.
• Develops staff through coaching, training, and other relevant experiences; builds high performance teams; and manages direct reports.
• As necessary reallocates projects across team members to facilitate both goal achievement and personal development.
• Operates effectively in a multi-tasking, cross-functional environment.
• Performs other duties as assigned.

QUALIFICATIONS:

• M.S. in Science concentration required, or Ph.D. preferred, preferably Pharmaceutical or Analytical Sciences.
• 10+ years’ (progressive advancement) in formulation design, characterization, and development in the pharmaceutical industry with leadership and management responsibilities.
• Excellent communication, interpersonal and management skills to collaborate on and direct the work of others on assigned projects (including both internal teams and external partners).
• Demonstrated knowledge, experience, and successful track record in formulation design, characterization, and development of a variety of IR and MR drug products.
• Sound knowledge of related aspects of the pharmaceutical research, development, and commercialization processes.
• Demonstrated ability to prepare technical sections of regulatory submissions and interact with regulatory authorities on technical matters.
• Demonstrated strong analytical and strategic thinking.
• Demonstrates a mastery of the scientific/technical concepts and techniques, applies and furthers those concepts and techniques to efficiently and effectively resolve scientific/technical issues.
• Excellent written and verbal communication skills.
• Able to positively influence and encourage sharing formulation selection/design/development and scale-up best practices (QbD) through effective presentations to internal and external audiences.