Theravance Biopharma is seeking a talented individual to join our Pharmaceutical Development group. The primary objective of this role is to carryout physicochemical characterization, develop enabling formulations for preclinical PK and safety assessment, evaluate the stability and developablity of preclinical formulations, and assist, as needed, in the clinical formulation development work.
Duties and Responsibilities
• Develop enabling formulations to support efficacy, PK and toxicology studies
• Conduct physicochemical characterization of lead compounds to guide preclinical formulations
• Conduct solid form screening for development compounds
• Prepare and supply formulations for internal and external preclinical studies
• Conduct stability studies to support the development of lead compounds
• Ensure the stability and reproducibility of formulations made-at or shipped-to CROs
• Write detailed protocols to facilitate the preparation of formulations by non-technical personnel at external sites
• Use analytical methods to assure the formulation compositions and concentrations
• Evaluate developability of lead compounds using microscopy, thermal methods, spectroscopy, X-ray diffraction, chromatography, particle size distribution analysis, and moisture sorption methods
• Manage and operate various instruments used in preclinical formulations
• Support clinical formulation development as needed
• BS, MS or PhD in Chemistry, Pharmaceutics or related fields
• 5-8 years (with BS) or 3-8 years (with MS) or 3-6 years (with PhD) of experience in the pharmaceutical industry working with preclinical formulations
• Understanding of various formulation approaches, drug delivery methods, and routes of administration
• Experience in pulmonary, ophthalmic, and/or dermatological formulations is considered advantageous
• Familiarity with different manufacturing instruments (e.g., homogenizer, nanomill, microfluidizer, spray dryer, dry mills, mixers, tablet press) and analytical instruments (HPLC, LC/MS, DSC, TGA, PXRD, DVS, IR, NMR, compound microscope, particle sizer)
• Ability to deliver under tight timelines and adapt to changing project needs
• Ability to work on multiple projects at the same time
• Ability to communicate, organize, and write well, and interact with other groups
The physical demands and environmental characteristics described below are representative of those that must be met by the incumbent to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties and responsibilities.
The incumbent may be required to sit, stand and walk for extended periods of time. The incumbent may be required to climb, bend, lift, carry and kneel. Because of the volume of work performed by computer and telephone, the incumbent will spend a considerable amount of time looking at the computer monitors and using his/her hands to operate office equipment.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.