Investigates, creates, and validates new scientific methodologies used to control raw materials, production intermediates, and final products on highly unique and complex projects. May be involved in pre-clinical, clinical, and/or post-marketing stages of drug development. Works on significant technical/scientific project activities to execute strategies and technical solutions that meet client needs and expectations through broad expertise. Participates in technical discussions with clients with a high level of technical proficiency. Engages in creation of processes and equipment design for clinical, scale up, and/or registration batches, including technology transfer of projects to and from clients. Evaluates and contributes to the design of manufacturing processes and supports problem solving as necessary with leadership and independent judgement. Typically works in a specific scientific area, such as analytical development, cell culture, purification, process validation, formulations, and/or manufacturing technical support. Makes decisions that frequently require developing new options to solve complex problems.
1. Interacts with top company leaders to develop scientific strategy. Leads strategic initiatives and solutions. Works closely with site management to optimize requirements of both client and site for portfolio of projects.
2. Leads development and coordination of realistic proposals and timelines. Leads meetings/teleconferences with clients.
3. Leads development of methods and processes that meet or exceed the expectations from clients and provide innovation as necessary.
4. Leads research of industry practices and processes and applies to innovative drug development internally and for client products. Presents recommendations internally and to clients.
5. Leads a team over multiple projects; manages team's project timelines and deliverables; may review group's financials.
6. Guides and advises during implementation of new methodologies and processes.
7. Leads resolution of problems related to the conduct of chemical experiments.
8. Liaises with internal scientific, analytical, and laboratory functional areas to meet project and team
9. Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices and Safety guidelines. Maintains the necessary compliance status required by company and facility standards.
Bachelors of Science in Chemistry, Biochemistry, Biology, or related physical science. PhD preferred.
Typically requires 12 years of progressive scientific experience, including 9 years in a related life sciences field. If related Master's degree, typically requires 10 years of related experience. If related PhD, typically requires 6 years’ experience. Experience working directly with clients.