Scientist/Manager
Location: San Francisco California
Description: Theravance, Inc. is looking of Scientist/Manager right now, this job will be placed in California. For complete informations about this job opportunity please give attention to these descriptions. Job Purpose
The main job activities include working with clinical and marketing teams to understand drug product requirements, designing and developing formulations, optimizing manufacturing proc! esses, 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 phar! maceutical science or related field with 5 â€" 10 years drug p! roduct 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
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If you were eligible to this job, please email us your resume, with salary requirements and a resume to Theravance, Inc..
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This job starts available on: Sun, 27 Oct 2013 09:27:08 GMT