Job Summary
Position is responsible for planning and execution of drug product development, technology transfer and validation activities between the Company and contract manufacturer (s) for manufacturing of commercial and clinical supplies including management of inventories.
This position is also responsible for coordination of stability testing at contract manufacturing laboratories and ensuring that all development activities are in compliance with applicable regulations and guidelines.
Qualifications:
- B.S. Chemistry, Biology or related, Advanced degree preferred
5+ years of experience in the product development in the Pharmaceutical Industry
Understanding of the drug development process and regulatory requirements for the development process and manufacturing
- Excellent written and communication skills
- Skilled in the use of computer tools for report writing and project planning & tracking
Exceptional written and verbal communication skills including ability to persuasively communicate
- Effective interpersonal skills with the ability to work in a team-based setting; flexibility; achievement-oriented with appropriate concern for quality are highly desirable qualifications
- Excellent analytical and problem solving skills; scientific and/or technical knowledge pertaining to pharmaceutical development or operations
Key Responsibilities
- Active communication with contract manufacturers to ensure that product development, commercial manufacturing and/or technology transfer activities are completed in a timely and cost effective manner
- Identify issues at contract manufacturers and take remedial actions if needed to prevent delays in timelines and deliverables
- Guide the formulation and analytical development activities at contract manufacturing and testing facilities
- Help identify appropriate partner companies for manufacturing, new formulation development and storage of materials
- Collaborate with other functional areas, e.g. regulatory, clinical, and commercial to understand plans for the development of new products, or demand for the commercial product
- Responsible for manufacturing and product development project timelines
- Help create and maintain project tracking tools to communicate progress, critical success factors and risk factors in the ongoing and planned drug product development projects
- Coordination of stability testing at contract laboratories. Organization of stability reports and preparation of the stability sections of regulatory submissions
