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Associate Scientist

Thousand Oaks, CA
Top 3 Must Have Skill Sets:    

• Ability to learn and act on dynamic information at a rapid pace
• Laboratory or pilot plant experience with process equipment
• Experience with establishing experimental design, developing and implementing protocols, acquiring reproducible and reliable results, analyzing data and communicating results

Description:

As a member of the process development team, this role will be passionate about identifying and developing aspects of drug product to advance process design for parenteral drug products. The candidate will perform experiments, coordinate data and analyze results with minimal direction. The candidate will establish the experimental design, develop and implement protocols, acquire reproducible and reliable results, analyze data and communicate results to multi-functional groups.
Specific responsibilities include but are not limited to:
• 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 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
• Participate in multi-functional teams working optimally in a highly matrixed team environment to inspire change, efficiency, and positive relationships
Preferred Qualifications
• MS in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology
• 3+ years 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
• 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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