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Associate Engineer

Thousand Oaks, CA
Top 3 Must Have Skill Sets:
  • MS in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology.
  • Experience in development/characterization of aseptic fill/finish unit operations (freeze/thaw, mixing, sterile filtration, filling, stoppering, visual inspection, etc.).
  • Experience in HPLC/UPLC (analytical chromatography), sub-visible particle analysis by HIAC and MFI, pH, UV-Vis measurements, osmolality, moisture content determination, viscosity, surface tension, density, etc.

Day to Day Responsibilities:
  • The candidate will perform experiments, organize data and analyze results with minimal supervision.
  • Additionally, the candidate will establish the experimental design, develop and implement protocols, obtain reproducible and reliable results, and communicate results to cross functional groups.
Ideal candidate-
  • MS Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology with 2+ years of analytical experience within the pharmaceutical/biotechnology industry.
  • Open to recent grads with 2+ years of lab experience and analytical testing.
Summary
  • As a member of the Drug Product Technology team, this role will be focused on identifying and developing aspects of drug product to advance process design for parenteral drug products.
  • This position involves an understanding and utilization of various analytical techniques to support formulation and process development of parenteral drug products.
  • The candidate will perform experiments, organize data and analyze results with minimal supervision.
  • Additionally, the candidate will establish the experimental design, develop and implement protocols, obtain reproducible and reliable results, and communicate results to cross functional groups.
  • Excellent written, oral communication, and presentation skills are required.
  • Specific responsibilities include but are not limited to:
  • Design, execute and document primary data packages related to drug product formulation and process development, and communicate key findings in presentations
  • Perform analytical techniques in a lab: HPLC/UPLC (analytical chromatography), sub-visible particle analysis by HIAC and MFI, pH, UV-Vis measurements, osmolality, moisture content determination, viscosity, surface tension, density, etc.
  • 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
  • Participate in cross-functional teams working effectively in a highly matrixed team environment to drive change, efficiency, and strong relationships
  • Adhere to company safety and training compliance requirements
Experience:
  • This position requires a BS in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry, Biotechnology, or a related field, with 0-2 years of relevant laboratory experience.
  • Preferred Qualifications
  • MS Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology with 2+ years of experience within the pharmaceutical/biotechnology industry
  • Experience in development/characterization of aseptic fill/finish unit operations (freeze/thaw, mixing, sterile filtration, filling, lyophilization, stoppering, visual inspection, etc.) to define critical process parameters
  • Experience in HPLC/UPLC (analytical chromatography), sub-visible particle analysis by HIAC and MFI, pH, UV-Vis measurements, osmolality, moisture content determination, viscosity, surface tension, density, etc.
  • 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
  • Organizational, technical problem solving, communication (written and verbal) skills, and regular interactions
  • Ability to learn and act on dynamic information at a rapid pace
  • Familiar or ability to learn to use electronic record keeping, GMP, laboratory notebooks, statistical analysis and software.
  • Laboratory or pilot plant experience with process equipment
     "This posting is for Contingent Worker, not an FTE"
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