The Product Development department is responsible for customer contracted new product development (Branded, Generic and OTC) as well as pro-active (Catalent owned) programs in softgel, liquid filled hard shell and liquid dosage forms. This area is also responsible for the development of intellectual property which provide improved outcomes for Patients and innovative solutions for our customers. Senior Director- Product Development is responsible for establishing a culture of innovation coupled with disciplined processes to develop and advance the development pipeline that fulfill unmet medical needs.
As a member of the Site Leadership Team - this position is accountable for all activities of the Product Development including Formulation, Process, Analytical development, and Project Management and is the primary liaison between the Product Development and key stakeholders from the business unit. This role will ensure the definition, development and implementation of product development activities associated with Formulation and Analytical development. The Senior Director will provide business and technical support throughout the entire drug development process and work directly with Scientists, Peers, Leadership, Scientists and customers to ensure a robust understanding of the business and technical challenges and associated risks with product development programs in the portfolio. The incumbent will assist in setting and delivering monthly, Quarterly and yearly PD revenue goals.
Specific Activities, and Responsibilities:
- Leads the activities of the Product Development area (Formulation / AR&D / Project Management) with responsibility for results.
- Implements and communicates the strategic and technical direction for the department. Determines immediate and long-term work plans/strategies for reporting groups; allocates resources for projects.
- Implement and enhance Catalent’s Softgel/LFHS/Liquid in Bottle development and innovation processes
- Design and execute the development plans for both customer and proactive projects
- Provides comprehensive project analysis to senior management as required in the form of reports or presentations as needed
- Responsible and accountable for the Financial (PD base costs, budget, and PD revenue) objectives
- Determines budget requirements for each fiscal year for reporting groups.
- Manages Capex programs as required for projects.
- Works on complex problems of diverse scope where analysis of data requires evaluation of intangible factors. Exercises independent judgment in developing methods, techniques, and evaluation criteria.
- Ensure robust, simple, phase appropriate processes are in place to support the execution of development activities in a timely manner
- Monitors and reports progress of projects within agreed timelines ensuring technical and financial goals are met.
- Technical liaison with customers to define objectives of projects and provide written/verbal reports on progress.
- Liaises with vendors/consultant/academic institutions as a senior technical representative.
- Effectively collaborates with Operations, QA, Regulatory, Finance, Engineering and other cross-functional areas
- Oversees preparation of CMC sections, technical and verbal reports and presentation on project progress.
- Working with Quality Assurance, develop SOPs and guidelines related to PD
- Ensures the group is compliant with current regulatory requirements.
- Comply with and ensure the group’s compliance with Health, Safety & Environmental responsibilities.
- Serve as a key member of Catalent’s Site Leadership team
- Assist Business Development with potential new development opportunities
- Identify improvements in organizational structure and processes
- Some travel may be required.
- Demonstrated experience building a team and collaborating cross-functionally
- Strategic thinking and in-depth understanding of the Pharmaceutical/healthcare sector
- Advanced evaluative, problem-solving and decision-making skills
- Leadership skills that are easily adaptable to all levels of management
- Strong written and verbal communication skills
- Ability to work under pressure with multiple tasks and deadlines
- Bias for action
Education and Experience
- Ph.D., in Pharmaceutical Sciences, Chemistry or related sciences with a minimum of 18years or MS/MBA with 20years in Pharmaceutical industry specifically in the drug product development area
- Experience with Oral drug product development covering NDAs (NCEs- POC through all phases of development), ANDAs, OTC Pharmaceuticals
- Professional experience with management responsibilities
- Experience of managing a large team of scientists and Project Managers in drug product development and Project Management
- Experience in leading and direct management of research, process development, and manufacturing
- Strong record of success in providing astute strategic leadership preferably within Pharmaceutical R&D organization
- A proven track record of driving product development from the lab all the way to commercialization and Technology transfer from PD to Operations and site to site
- Proven skills in evaluating, building and motivating teams
- Skills in setting high goals for personal and group accomplishments using measurement methods to monitoring progress in achieving the goals
- Ability to work in a Matrix organization and establish harmonious and productive (internal customers and external customer) working relationships
- Deep knowledge and understanding of drug approval process and FDA regulations
- Excellent written and verbal communications skills in English with the ability to present to a wide range of audiences including Senior Management
- Experience in solid and liquid formulation development and novel pharmaceutical delivery systems, Deep knowledge of Project Management, Technology transfer required. Basics of business financial is helpful.
- Proficiency in analysis of scientific data and results with ability to review scientific documents including reports, publications, and regulatory submissions
- Prepared and managed the preparation of CMC regulatory filings
- Mathematical and reasoning ability
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
- Ability to work effectively under pressure to meet deadlines. Individual may be required to sit, stand, walk regularly and occasionally lift to 15 lbs; no lifting greater than 44 lbs without assistance.
- Be accessible to laboratory and pilot plant area(s) and office staff and to use required office equipment.
- Specific vision requirements include reading of written documents and frequent use of computer monitor screen