Job Description

• 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 client 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 cross-functional teams working effectively in a highly matrixed team environment to drive change, efficiency, and strong relationships

• MS 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
• 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

• BS in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology with 3+ years of experience within the pharmaceutical/biotechnology industry

• 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, especially aseptic fill/finish unit operations (freeze/thaw, mixing, sterile filtration, filling, stoppering, visual inspection, etc.)
• Ability to learn and act on dynamic information at a rapid pace
• Degree: BS with 3 years of experience (minimum) -Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry

• Engineer will be involved with development/characterization of aseptic fill/finish unit operations (freeze/thaw, mixing, sterile filtration, filling, stoppering, visual inspection, etc.) to define critical process parameters.
• Engineer will assist with aseptic fill finish manufacturing or manufacturing technical services activities including the development of control strategies and active process performance monitoring
• Engineer will perform stability or characterization studies to understand process related stresses that impact the quality and stability of biologics
• Engineer will apply engineering principles to leverage bench and pilot scale models for process performance characterization
• Engineer will be involved with 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.)