Engineer

03 Aug 2024

Vacancy expired!

Requirements:
  • Experience in drug product filling
  • Laboratory or pilot plant experience with process equipment
  • BS in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology
  • 3+ years of experience within the pharmaceutical/biotechnology industry
  • Experience in development/characterization of aseptic fill/finish unit operations (freeze/thaw, mixing, sterile filtration, filling, stoppering, visual inspection, etc.) to define critical process parameters
  • Aseptic fill finish manufacturing or manufacturing technical services experience including the development of control strategies and active process performance monitoring
  • Understanding of process related stresses that impact the quality and stability of biologics
  • Ability to use engineering principles to leverage bench and pilot scale models for process performance characterization
  • Fill/finish process scale-up and technology transfer experience including the use of gap analysis, root cause analysis, and risk assessment tools (e.g. Fish bone diagrams, FMEA, etc.)
  • Familiarity with Design of Experiments (DOE) and Quality by Design (QbD) principles
  • Familiarity with cGMPs, regulatory filings, and compliance issues for sterile injectable products manufactured by aseptic processing
  • Experience in a matrix team environment and interacting with Analytical Sciences, Process Development, Project Management, Manufacturing, Regulatory, Compliance, and/or Quality
  • Familiar or ability to learn to use electronic record keeping, GMP, laboratory notebooks, statistical analysis and software.
  • Job Description:
  • 50% onsite
  • Perform experiments, organize data and analyze results with minimal supervision.
  • Establish the experimental design, develop and implement protocols, obtain reproducible and reliable results, analyze data and communicate results to cross functional groups.
  • Design, execute and document primary data packages related to drug product design and process development, and communicate key findings in presentations
  • Develop solutions to technical problems during process characterization and aseptic manufacturing
  • Support one or more clinical and commercial process introductions or process transfers into Amgen manufacturing network
  • Author and review technical protocols, reports, product impact assessments, and regulatory sections in support of IND and marketing application submissions
  • Provide ongoing support to clinical and commercial fill/finish manufacturing operations through troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements
  • Equal Opportunity Employer/Veterans/Disabled

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    The Company will consider qualified applicants with arrest and conviction records

    • ID: #44552929
    • State: California Simivalley 93062 Simivalley USA
    • City: Simivalley
    • Salary: USD TBD TBD
    • Job type: Permanent
    • Showed: 2022-08-03
    • Deadline: 2022-10-01
    • Category: Et cetera