To lead the group responsible for the development of pharmaceutical dosage forms,
and to execute pharmaceutical portions of technology transfers. To assure that
products, processes, and/or procedures are rapidly developed and meet customer
expectations and all applicable regulatory requirements.
1. Ensure the rapid development of new dosage forms and processes according to
customer requirements. Assure that processes are safe, reproducible, cost
effective, environmentally sound and can be successfully validated and
transferred to production operations, in order to meet agreed standards and
require minimal continuing support. Look for ways to improve customer
2. Assist Marketing in obtaining clients and business partners. Review technical
packages, develop project proposals and provide information to be included in
3. Manage the production of clinical supplies such that customer and regulatory
requirements are met. 2
4. Ensure that the Chemistry, Manufacturing, and Controls portion of regulatory
submissions are based on sound science and written to current standards with
the reviewer in mind. To be accountable for the preparation of appropriate CMC
5. Work with Client Departments to introduce new technology and resolve problems,
6. Define resource needs (capital, expense, and headcount) so that current and
future development needs are met. Recruit, hire, retain, train, and motivate a
scientifically competent staff. Provide opportunities for staff career development.
7. Performs other duties as assigned.
BS/BA with 7 years relevant experience OR
MS with 5 years relevant experience OR
Ph.D. with 3 years relevant experience
9 years experience with a degree in a related scientific field.
-Demonstrated ability to manage and lead professional staff in order to achieve goals,
evaluate and resolve complex technical problems. Ability to motivate, energize, and
retain key staff by direct interactions with supervisors and staff. Must have a broad
based knowledge of product development/product manufacturing or analytical
development/testing techniques, as appropriate, and CMC regulatory requirements.