Main Tasks and Responsibilities

Formulates oral solid dosage forms in a fast-paced contract manufacturing environment Develops a wide array of formulations including immediate and modified release for Phase I-III of clinical trials Conduct pre-formulation, formulation, manufacturing process development/optimization for various solid dosage 
formulation and process development work. Interacts with clients to produce deliverables with aggressive project timelines Authors product specifications, process validation protocols, batch records, and developmental reports Works cross functionally with QA and Analytical Development activities to ensure successful product delivery Manufactures and packages clinical supplies for Phase I-III clinical trials under CGMP standards Trains manufacturing scientist and technicians.

 

Qualifications and Experience Required for Competent Performance

Knowledge: The factual and procedural information required to perform the role

Master’s degree in Pharmaceutical Science, Chemical Engineering, or other related field of study with 1-2 years of experience in the pharmaceutical industry preferred. In lieu of a of a Master’s degree in Chemistry, or related field, or foreign degree equivalent plus two (2) years of experience in the pharmaceutical industry, the employer will accept a Bachelor’s degree in the same fields, or foreign degree equivalent, plus three (3) years of experience in the pharmaceutical industry Experience with immediate release, modified release, solid oral dosage forms, and high potent formulation Knowledge of federal and state regulations and guidelines including FDA, EPA, OSHA, and DEA Knowledge of chemical components and theories Knowledge of solid oral production process

 

Skills: The effective use of knowledge and abilities in performance. 

Proficiency in Microsoft Office Suite Read and interpret documents such as safety rules, operating and maintenance instructions, and standard operating manuals Write routine reports, business correspondence, and standard operating procedure manuals Apply mathematical operations to tasks such as frequency distribution, determination of test reliability and validity, analysis of variance, corollary techniques, sampling theory and factor analysis   Define problems, collect data, establish facts, and draw conclusions Interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables Ability to working in a hazardous environment with high requirement to follow safety procedures Use instruments, equipment, and technology safely and effectively