Essential Duties and Responsibilities: This role requires experienced formulation and process development scientists with project leadership experience in development of pharmaceutical solid oral dosage form products and manufacturing processes. Will provide science & technology guidance in support of client projects in various product development and manufacturing activities within time and budget constraints. Guidance will be provided to all levels within R&D, Manufacturing, Business Development, Quality, and Executive Management. Major activities include: contract proposal review; business development support; technical guidance for project leaders and participation in design of formulations and manufacturing processes; evaluation & implementation of new technology & equipment; attend team meetings; review documents; answer technical questions and participate in discussions; presence on mfg floor or lab during critical operations; write technical reports; advise on procedural, document, and batch record questions; advise registration and validation activities; and many other lesser activities.
Pharmaceutical formulation development experience is required. Preference for CDMO (contract development and manufacturing operation) experience with solid oral dosage forms and a PhD, but not required.Academic study of industrial & physical pharmacy, pharmaceutical chemistry, chemical engineering, chemistry, or biochemistry; skill in the science & art of pharmaceutical product development; experience & knowledge of pre-formulation, formulation development, clinical manufacturing, analytical testing, quality control & assurance, cGMP, & GLP; knowledge of programs like Outlook, Word, Excel, Access, TrackWise, and Documentum; knowledge of contract development, concept product development, clinical phase 1, 2, and 3, biobatch, registration, and validation; experienced with IND/NDA/ANDA, QBD, CPP, DOE, and RLD activities; detail oriented, a self-starter, excellent organization & communication skills; ability to handle multiple tasks involving various departments in a fast-paced environment; effective interpersonal skills; ability to read, analyze, interpret, & write scientific documents/reports; the will & ability to achieve success.
UPM Pharmaceuticals is a Bristol Tennessee based contract development and manufacturing organization (CDMO) serving the pharmaceutical and biotechnology industries. UPM provides high quality pharmaceutical drug development services that include formulation development, cGMP manufacturing and packaging, analytical method development and testing from concept through commercialization.
UPM is cha...racterized by its strict sense of quality, timeliness, sound scientific fundamentals, and affordability with which we complete all our projects. We focus on drug development and manufacturing for dosages with oral routes of administration in solid forms such as capsules and tablets, and semi-solid creams and ointments.