Description
QUALIFICATIONS * PhD in Pharmaceutics and trained in working with GLP compliance * Direct working/collaborating experience with CMOs and CROs * Wide experience in preformulation/formulation design and development for preclinical study: solution, suspension, semisolid and solid formulation. Hand on experience with DoE (JMP) for optimization of drug formulation * Hand on experience on INDs/NDAs filing: protocols, product development reports, batch records, product specifications, validation reports, CMC, SOPs * Solid experience on Analytical / Bioanalytical Method Development, Validation, Transfer and Quality Control (HPLC, LC-MS/MS) * Fundamental acknowledgement and strong experience in DMPK * Hand on experience with managing the scale-up and manufacturing of semi-solid dosage forms * Solid understanding on the process of drug discovery and development * Internship experience with mid-sized pharmaceutical company and working in dynamic environments * Excellent leadership, teamwork and organizational skills * Solid verbal and written communication skills and strong data analysis skills * Highly self-motivated and "CAN DO" attitude