Theravance, Inc. - San Francisco, CA

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Job Purpose
The main job activities include working with clinical and marketing teams to understand drug product requirements, designing and developing formulations, optimizing manufacturing processes, and working with CMO to develop, scale up and manufacture CTM for clinical studies.

Duties and Responsibilities
  • Design and conduct formulation development, process development, process optimization, scale-up, process validation, and GMP CTM manufacturing on assigned projects
  • Prepare and review manufacturing batch records, product development report and other development-related documents
  • Work in CMC and project teams to support drug product development, CTM manufacturing, and regulatory filing.
  • Work as part of multi-discipline cross-functional teams to ensure development of products in a timely and cost effective manner
  • Evaluate, select and manage contract manufacturers for drug product development scale up and GMP drug product manufacturing
  • Evaluate, select and manage contract manufacturers for CTM packaging, labeling and distribution

Job Requirements: Qualifications
  • Ph.D in pharmaceutical science or related field with 5 – 10 years drug product development experience
  • Experience with parenteral drug products development and GMP drug product manufacturing
  • Experience in parentaral drug product IND/NDA regulatory filing
  • Experience in selecting and managing CMO’s for drug product development and manufacturing
  • Strong Interpersonal skills
  • Ability to communicate clearly, concisely, and effectively in both written and oral context
  • Proficiency with Microsoft Office Suite, strong Excel skill
  • Capable of compiling, analyzing and presenting data in a concise manner
  • Capable of working on multiple projects/tasks and able to meet timelines