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Formulation Scientist/ Senior Scientist

Company: Coherus BioSciences
Location: Camarillo
Posted on: November 23, 2022

Job Description:

Title: Formulation Scientist/Senior Scientist Reports To: Executive Director of FormulationsLocation: Camarillo, CA Classification: Exempt Overview: This position will provide technical leadership for the development of formulations for 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, commercial manufacturing on site full time. Responsibilities also include working closely with Quality and CMC counterparts as well as any necessary analytical method development, specification development, and assessment of stability data/programs.Responsibilities:

  • Independently performs and implements formulation strategies
  • Develop of inject-able biologics dosage forms following quality by design (QbD) principles and executes small & large scale stability studies
  • Identifies drug product critical quality attributes impacting safety, efficacy, and manufacturing robustness; provides input to define phase appropriate regulatory specifications
  • Performs screening of formulation components, e.g.: buffers, excipients, solubilizers, etc.
  • Provides pre-formulation characterization of preclinical and clinical compounds
  • Performs method development and characterization activities when needed
  • Author and review of written documents including development reports, technical memos, etc. for Formulation development, Analytical Development, QC/QA, DS/DP manufacturing, and Device Engineering
  • Serves as formulation lead in multidisciplinary project teams and/or sub-teams
  • Manages formulation studies/activities performed in-house and at contract research organizations (CRO)
  • Provides technical formulation guidance to contract manufacturing organizations (CMO)
  • Work effectively in a cross-functional matrix environment, with internal and external customers and proactively communicate with internal and external stakeholders
  • Authors applicable sections of regulatory submissions and answers Health Authority questions as appropriate
  • Serves as SME for formulation during onsite FDA inspections Qualifications:
    • Scientist: 1-2 years of relevant experience with MS or PhD degree in related scientific discipline, or 8+ years of industry experience with BS degree in related scientific discipline
    • Scientist: 3-5 years of industry with an MS or PhD degree in related scientific discipline, or 10+ years of industry experience with BS degree in related scientific discipline
    • Will have expert understanding and knowledge 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 troubleshoot technical problems
    • Detail oriented, with good organizational skills and project management skills
    • Able to work in a fast paced team environment, meet deadlines, and prioritize work on multiple projects
    • Excellent oral and written communication skills Beginning July 19, 2021, Coherus BioSciences requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Coherus BioSciences, and it applies regardless of whether the position is located at a Coherus BioSciences facility or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

Keywords: Coherus BioSciences, Camarillo , Formulation Scientist/ Senior Scientist, Other , Camarillo, California

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