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Formulations Scientist

PURPOSE:
The Research and Development group at INSYS Therapeutics is responsible for Pre-formulation, Formulation Development, Clinical supplies manufacture and release of drug products under development.
RELATIONSHIPS:
Reports to the Director, Research and Development. Internal relationships include Formulation Scientists, Analytical Scientists, Quality Assurance, Regulatory Affairs, Clinical and outside vendors.

Essential Functions:
Extensive literature survey on active drug molecules and Pre-formulation including drug characterization, solubility determination, excipient compatibility assessment.
Design, direct and/or conduct pre-formulation, formulation development, process development, process optimization, scale-up and clinical manufacturing on assigned projects.
Lead efforts on new product candidate selection, technology development and patent filings/prosecution.
Development of new and innovative dosage forms, and improve existing ones.
Write and review documents such as Product Development Reports, Master Batch Records (MBR), SOPs, Specifications, Stability protocols etc.
Write and review Chemistry Manufacturing Control (CMC) sections of the Investigational New Drug Application (IND) and New Drug Application (NDA) for submission to the Food and Drug Administration (FDA).
Overseeing clinical and commercial manufacturing at Contract Manufacturing Organizations (CMOs) and guide then on necessary process changes.
Work closely with analytical scientists in analytical method development and drug product stability assessment.
Guide entry level formulators and technicians/associates to develop pharmaceutical products.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
Required: Degree in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering or chemistry related field
Zero (0) to two (2) years of formulation development experience in the Pharmaceutical Industry, with PhD; two (2) to four (4) years with M.S.; four (4) to six (6) years with a B.S.
Ability to travel up-to 10%
Excellent verbal and written communication skills
Preferred:
Ph.D. with 1-2 years direct experience in formulation and analytical development.
"Hands on" experience in development and evaluation of different pharmaceutical dosage forms, processes, and equipment is required.
Prior experience in handling analytical instrumentation such as HPLC, GC, UV/VIS.
Capacity to independently manage multiple projects in dynamic environment and to work intra- and interdepartmentally using a team approach to accomplish goals.
A thorough knowledge of GMP.




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