Research Associate II – Associate Scientist, Analytical Development

Location
South San Francisco, California
Posted
May 15, 2018
Ref
1124455
Discipline
Science/R&D, Chemistry
Required Education
Bachelors Degree
Position Type
Full time

Job Purpose

Theravance Biopharma is an established, progressive biopharmaceutical company focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections and gastrointestinal disorders. Our promising pipeline of internally discovered product candidates and strategic partnerships are elevating us to the next generation of drug discovery.

We have an opening for a Research Associate II to Associate Scientist position in Analytical Development (title commensurate with experience and skillset). This position will be part of a fast-paced analytical team responsible for supporting small molecule drug substance and drug product development. 

Duties and Responsibilities

This is primarily a laboratory position working under a regulated (GMP) setting.  Specific duties and responsibilities may include:   

  • Release and stability testing of clinical drug substance and drug product, as well as informal studies supporting drug substance and drug product development
  • In-process control testing for in-house clinical drug substance manufacturing, as well as raw/starting materials and intermediates release testing
  • Validation/verification testing (primarily HPLC, GC, Karl Fischer)
  • Drafting test methods and method validation protocols and reports
  • Rotational duties in matrixed generic testing (i.e., GC residual solvents, IC, Karl Fischer)
  • Dissolution testing of solid oral dosage forms
  • Spectroscopic (FTIR, UV/Vis) and thermal (DSC, TGA) techniques
  • Other compendial testing (ROI, Heavy Metals)
  • Analytical method development and impurities characterization by MS opportunities (commensurate with experience)
  • Effective, timely documentation in notebook and LIMS

Qualifications

  • Minimum requirement for Research Associate II level:  Bachelor’s degree in chemistry (or a related discipline) with at least three years of relevant industrial experience or, alternatively, a Master’s degree with at least one year of relevant industrial experience
  • Minimum requirement for Associate Scientist level:  Bachelor’s degree in chemistry (or a related discipline) with at least seven years of relevant industrial experience or, alternatively, a Master’s degree with at least four years of relevant industrial experience
  • Technical proficiency in analytical development (e.g., compendial testing, separation sciences, dissolution, spectroscopy and hyphenated technology)
  • Prior experience in analytical method development and mass spectrometry is preferred for the Associate Scientist level
  • Prior experience working in a regulated laboratory setting (GMP/GLP) in compliance with internal guidelines and SOP’s
  • Prior experience with Waters Empower data acquisition and analysis platform is preferred
  • Knowledge of scientific principles, laboratory skills and a commitment to laboratory safety, as well as the capability to effectively and critically apply these in daily activities
  • Excellent oral and written communication skills
  • Capability to work independently and to multi-task effectively