FORMULATION ASSOCIATE

EDUCATION, EXPERIENCE, AND TRAINING REQUIREMENTS Education: Bachelors technical degree from a four year college or university, preferably In Pharmaceutical sciences, and/or chemistry. Advance course work or Master degree is preferred. Experience: Must have at least one year experience in Pharmaceutical product development. Knowledge: Specific knowledge of industrial chemistry pertaining to product area. Preferred skills/Qualifications: Computer skills (MS office); critical thinking; oral and written communications skills. Skills/Competencies: Excellent communication skills in one-on-one and group situations. Skills to prepare written procedures and reports. Ability to work effectively in a team atmosphere. Must be a team player with ability to interact effectively with other departments. GENERAL RESPONSIBILITIES / FUNCTIONS Participate in preformulation and formulation development studies. Manufacture of stability batches within the laboratory area or pilot plant. Participate in process development and validation studies where required. Prepare technical documentation to support development work and manufacturing (includes master batch records and process validation documentation), standards & specifications for processes and Products. Literature search, Patent search, and evaluation. Development of non-infringing formulation. Process scale up and manufacturing of pharmaceuticals which includes activities like granulation, blending, tabletting, coating and encapsulation etc. Handling in-process manufacturing equipment like granulators, blenders, automated coating machines, compression machines and capsule filling machines. Technical documentation support for ANDA submissions & other USFDA regulatory submissions. Trained in cGMP, ICH & FDA guidelines.