Sr Scientist, Process R&D - South San Francisco, CA | Biospace
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Sr Scientist, Process R&D

Theravance Biopharma US, Inc.

South San Francisco, CA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Areas of Expertise Desired:
Development, Process, Research, Scientist, Senior Scientist,

Job Description

Theravance Biopharma is seeking a talented individual to join our Process Research and Development group. The objective of this role is to develop, optimize and implement synthetic processes and manage process development and scale-up activities for early to mid-stage drug candidates.

Key Responsibilities for this role include:

•   Develop novel synthetic processes and prepare drug substance to support lead selection and early development
•   Conduct process optimization, technology transfer and support of scale-up and manufacture of drug substance to support clinical and non-clinical studies
•   Participate as the functional representative on multiple projects to provide technical expertise in cross-functional CMC and project teams
•   Communicate progress against objectives effectively to scientists and management at all levels
•   Coordinate with other groups within the company to ensure timely availability of drug substance for nonclinical and clinical studies


Basic Qualifications

•   Ph.D. with at least two years of experience in the pharmaceutical industry working with small molecule new chemical entities (NCEs)
•   Senior Scientist should have a minimum of three years of effective performance at the Research Scientist level
•   Demonstrated expertise in synthetic organic chemistry, process development, scale-up and optimization from laboratory scale to pilot scale.
•   In-depth familiarity with analytical methodology used for characterization of drug substance and drug product properties
•   Knowledge of statistical design of experiments is preferred
•   Experience with technology transfer of outsourced projects at contract manufacturers is a plus
•   Extensive understanding of other disciplines related to Process R&D and demonstrated cross-functional experience
•   Familiarity and training in GLPs, GMPs, INDs and other regulatory requirements is desirable
•   A track record of scientific productivity as evidenced by high quality publications and/or patents
•   Skilled at preparing technical documents such as development reports, protocols, SOPs, CMC sections of INDs, etc.
•   Skilled at presenting data and strategy in scientific settings and team meetings
•   Ability to work in multi-disciplinary teams under defined timelines
•   Capable of motivating others and providing input for self-development
•   Excellent leadership, supervisory, communication, teamwork and organizational skills