Senior Scientist, Biologics Formulation

Richmond, CA, United States
Sep 30, 2020
Required Education
High School or equivalent
Position Type
Full time
The Formulation Senior Scientist will provide technical leadership for the development of pre-clinical and early clinical stage candidates forms following quality by design (QbD) principles for the delivery protein-based therapeutic agents. The successful candidate will be expected to drive programs from inception through pre-clinical manufacture/screening, technology transfer, early cGMP manufacture, working closely with Quality and CMC counterparts as well as any necessary analytical method development, specification development, and assessment of stability data/programs.

Essential Duties and Responsbilities:

  • Independently performs and implements formulation strategies
  • Development of inject-able biologics dosage forms following quality by design (QbD) principles.
  • Identifies drug product critical quality attributes impacting safety, efficacy, and manufacturing robustness. Provides input to define phase appropriate regulatory specifications.
  • Performs screening of buffers, excipients, solubilizers, etc
  • Pre-formulation characterization of preclinical and clinical compounds.
  • Authoring and review of written documents including development reports, technical memos, etc.
  • Serves as formulation lead in multidisciplinary project teams and/or sub-teams.
  • Responsibilities for equipment maintenance and calibration, housekeeping, and other support functions (e.g., inventory of consumables and reagents).
  • Work effectively in a cross-functional matrix environment, with internal and external customers and proactively communicate with internal and external stakeholders.

Required Experience / Skills

  • 3-5 years' industry experience with MS or PhD degree in related scientific discipline, or 6+ years' industry experience with BS degree in related scientific discipline.
  • Will have expert understanding of pre-formulation and formulation area and uses published literature to extend understanding as well as consulting internal and external experts as needed.
  • Highly independent and self-motivated and integrates well within a team.
  • Ability to establish and maintain effective working relationships.
  • Strong ability to trouble-shoot technical problems.
  • Detail oriented, with good organizational skills and project management skills.
  • Able to work in a high paced team environment meet deadlines and prioritize work on multiple projects.
  • Excellent oral and written communication skills.

Location: Richmond, CA 94806

Work authorization: United States (Required)