AD - Director, Pharmaceutical Development
Theravance Biopharma is seeking a talented individual to join our Pharmaceutical Development group. The primary objective of this role is to lead early stage preformulation and preclinical formulation development efforts in oral, topical, pulmonary, and ocular drug delivery, design and execute enabling formulations for preclinical PK and safety assessment, evaluate the stability and developability of preclinical formulations, assess the suitability of lead candidates for development by working on their physicochemical and solid-sate properties, develop strategies for clinical formulation, and conduct manufacture of clinical trial materials for early clinical studies.
Duties and Responsibilities
- Assess physicochemical and biopharmaceutical properties of lead candidates and design phase-appropriate preclinical formulations to support PK, PD and nonclinical safety studies.
- Prepare and supply formulations for internal and external preclinical studies.
- Conduct stability studies to support the development of lead compounds.
- Manage CROs for development and manufacture of desired nonclinical formulations.
- Manage and operate various instruments used in preclinical formulations.
- Perform and lead physicochemical characterization and solid form screening of advanced and development candidates.
- Write, review, and approve technical reports, and relevant sections INDs, NDAs, and other regulatory filings.
- Develop early clinical formulations consistent with preclinical formulations used in topical, ocular, or pulmonary formulations used in nonclinical safety studies.
- Prepare prototype clinical formulations, evaluate stability, conduct tech transfer, and develop and manufacture engineering and GMP drug product for early stage clinical studies.
- Keep abreast of drug delivery by the oral and topical or ocular or pulmonary routes and continuously evaluate and incorporate novel delivery systems and techniques.
- PhD in Chemistry, Pharmaceutics or related fields.
- More than 10 years of experience in the pharmaceutical industry working with preclinical formulations.
- Understanding of various formulation approaches, drug delivery methods, and routes of administration, specifically topical, ocular (surface and intravitreal), and pulmonary routes.
- Demonstrated expertise in both early and late stage development and experience with good manufacturing practices.
- Working knowledge of relevant ICH and FDA guidelines.
- Broad scientific understanding of solid state chemistry, physicochemical profiling, formulation and drug product development, and anatomical and physiological differences between preclinical species and humans for different delivery routes.
- 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.