Participate in formulation development and evaluation of preclinical, clinical, and commercial parenteral and oral drug dosage forms and container/closure systems. Perform preformulation studies on drug substances and stability studies on drug products. Typical activities will include preparation of liquid and solid dosage form of new chemical entities and stability assessment of drug products used in preclinical studies.
Key Accountabilities/Core Job Responsibilities:
Compound pre-clinical formulations of novel drug molecules
Formulate and evaluate clinical parenteral and oral dosage forms and characterize samples using HPLC, USP dissolution apparatus, etc.
Setup development stability studies for drug product and analyze samples at designated time points.
Perform data analysis and generate statistical data and table/graphs of study results.
Other duties may be assigned
Basic understanding of cGMP, GLP and SOP
Knowledge and experience in HPLC, UV/vis, spectrophotometry, USP dissolution analysis
Computer proficiency (PC, word processing and spreadsheet)
Good time management and organizational skills
Thorough and accurate documentation skills with attention to detail
Able to communicate effectively with all levels of personnel
2-5 years of relevant experience, preferably in pharmaceutical industry.
Education Requirements (degree, certifications, etc.): Include must have and preferred
BS or MS in chemistry or pharmaceutical sciences
State or Province