Principal Development Scientist (Preformulation) Grade: S10 / Ref: AMLN-02759 Regular F/T
Location: San Diego, California
RESPONSIBILITIES: Lead and mentor a team of scientists in developing and analyzing new peptide/protein formulations for various clinical and/or commercial applications Create budget for projects and capital equipment to keep lab functional and technologically advanced. Manage resources, keeping projects on track and meeting dept. & corporate goals. Develop strategy/plan in support of company vision of testing two new medicines in man a year (TIMY). Formulate stable dosage forms consistent with preclinical and clinical needs Develop new chemical and physical test methods. Identify destabilization mechanisms occurring in peptide/protein formulations. Solve scientific problems encountered during the development of drug substances and drug products. Evaluate new excipients, stabilizers, and additives to maintain the stability of peptides/proteins. Establish new intellectual properties and assess patent opportunities. Conduct due diligence. Write technical reports and present scientific results at internal and external meetings. Write sections of INDs, BLAs, NDAs, IBs, clinical protocols, and Annual Reports. Supervise the work of technical personnel with a special regard to accuracy and reliability of their data. Ensure the adherence to SOPs and departmental policies. Train and provide work direction to scientists and research associates. Maintain and enforce safety regulations in the work area.
REQUIREMENTS: PhD in chemistry, biology, or engineering with 10-14 years of combined research and development experiences; supervised for a minimum of 6 years; strong scientific background and extensive knowledge base; good communication skills; work in cross-functional project teams; maintain a high level of productivity, creativity, and scientific reasoning; ability to adapt quickly to changing timelines.
Vladi V Wilent, PhD
Amylin Pharmaceuticals, Inc
San Diego CA 92121