|
Job Description
|
BIOLOGICS EXPERIENCE AND CMO OVERSIGHT IS A MUST HAVE!!!!!!
RESPONSIBILITIES:
• Provide technical support and routine process monitoring for commercial products manufactured at CMOs.
• Provides person-in-plant observations of manufacturing operations at CMOs and communicates observations to the product team.
• Reviews manufacturing processes, deviations, and/or development and production data.
• Reviews manufacturing batch records, protocols, and control strategies.
• Provide technical support and data analysis for investigations and deviation resolution.
• Recommends changes or additional experiments to improve quality, productivity, recovery, and overall efficiency.
• Interacts with colleagues and external partners from various functions, such as Engineering, Manufacturing, and Quality departments
• Oversees and reports on overall manufacturing progress.
BASIC QUALIFICATIONS
• Bachelor’s degree in engineering or science with 8 years of experience
OR
• Master’s degree in engineering or science with 5 years of experience
• Experience in biologics development, bioprocess engineering, technology transfer, and / or commercial manufacturing operations
PREFERRED QUALIFICATIONS
• Experience with Good Manufacturing Practices and supporting a commercial facility
• Experience in cell culture and/or downstream purification (direct lab experience a plus)
• Experience with equipment qualification and process validation
• Familiarity with formal root cause analysis and/or risk assessment
• Experience working with statistical analysis software and investigative data analysis
• Experience with project leadership
• Experience communicating with cross functional teams
• Strong technical writing and communication skills
• Proficient in Microsoft Word, Excel, and PowerPoint
|