The principal Formulation Scientist will develop solid dosage form product from design of formulations to scale-up and technology transfer.
DUTIES/RESPONSIBILITIES:
· Design formulations of solid dosage form and experiments, especially modified release products.
· Conduct experiments with the assistant of technician or junior scientist.
· Manage multiple development projects and develop formulations in a timely manner.
· Write protocols, master manufacturing records, and product development report.
· Support Regulatory Affairs for IND/NDA/ANDA filings.
· Provide support to production in process improvement and troubleshooting.
· Stays current with recent advances and trends in the drug delivery technology and regulatory policies.
· Participate in preparing, managing, controlling and maintaining the departmental budget.
· Represents department in corporate project review meetings.
· Trains and supports staff for professional growth.
EDUCATION/SKILLS:
· A minimum of 5 years of experience in the pharmaceutical industry with an advanced degree in Pharmaceutics or Chemical Engineering. Ph.D is plus.
· A proven track record of development of solid dosage products and progressive responsibility including leadership within a generic pharmaceutical organization.
· Knowledge and hands-on experience with various equipment used in the development and manufacturing of solid dosage forms.
· Effectively managing multiple projects, duties and assignments.
· Demonstrated understanding of USP, FDA, and ICH requirements for drug products and product development.
· Effective communication skills.
