Pharmaceutical Development:
Senior Research Associate, Solid Forms
Job Purpose: Theravance is a biopharmaceutical company that offers stimulating, challenging and productive environment.
Theravance is seeking a talented individual to join our Pharmaceutical Development group. The primary objective of this role is to identify and investigate crystalline forms of Theravance compounds, conduct solid form characterization in early development, design and develop crystallization processes for drug substance, and ensure selection of the most appropriate solid form for development compounds.
Duties and Responsibilities: • Conduct salt and polymorph screening studies for development compounds • Evaluate physicochemical and material properties of compounds using techniques such as microscopy, thermal methods (DSC, TGA), diffraction (PXRD), spectroscopy (IR and Raman), and moisture sorption. • Address development challenges for drug substance and drug product related to solid form properties • Prepare high quality reports that illustrate the technical depth and propose suitable forms for further development • Maintain and operate laboratory equipment and analytical instrumentation in the Solid Forms laboratory • Design and execute experimental programs to develop, optimize, and scale-up crystallization processes for drug substances • Coordinate with other groups within the company to ensure smooth transition of projects from early to late stage and CMC development • Represent the group in cross-functional project teams and provide technical expertise
Qualifications: Preferred Qualifications • BS or MS in Physical Chemistry, Physical Pharmacy, Chemical Engineering, Chemistry or related fields • 4-8 years (with BS) or 2-4 years (with MS) experience in the pharmaceutical industry working with small molecule new chemical entities (NCEs) • Knowledge of crystal structures, polymorphism, phase transformations, amorphous compounds, and physical properties including the application of analytical tools (e.g. XRD, DSC, TGA, HPLC, IR, Raman, DMS, particle size distribution) • Expertise in crystallization development, scale-up and optimization from laboratory scale to pilot scale • Experience in recommendation of solid forms for development based upon bioavailability, manufacturing complexity and solid-state attributes • Familiarity with oral solid dosage forms is a plus • Thorough understanding of other disciplines related to solid forms development • Training in GMPs and regulatory requirements, experience with INDs is a plus • Be able to conduct research and make high quality contributions both independently and as a member of multi-disciplinary teams under defined timelines • Skilled at presenting data and strategy in scientific settings and team meetings • Excellent communication, teamwork, organizational and problem solving skills
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