Qualifications: Experience with deviation management organization in pharmaceutical / biotech companies. Previous experience with culture techniques, virology, aseptic processing and sterile manufacturing, biologics process development or manufacturing and / or process equipment. Familiar with Lean Six Sigma methodologies. Minimum 1-3 years post-bachelors degree experience in Production, Development or related field. Good interpersonal skills including flexibility and ability to work in a team environment. Excellent written and verbal communication skills. Skillful in writing investigations for atypical events in a manufacturing environment. Proven experience with troubleshooting in a manufacturing environment.
Responsibilities: Primarily responsible for reliable day-to-day technical support for manufacturing, including resolution and reduction of process deviations, development and implementation of corrective / preventative actions, and leading manufacturing and laboratory investigations. Specifically, this individual may be responsible for providing scientific support for bulk manufacturing areas. Troubleshooting and root cause analysis of laboratory test failures and manufacturing atypicals and development of corrective actions. Analysis of complex processing problems through critical analytical thinking and the design / execution of laboratory / pilot scale experiments. Development of sound scientific justification to ensure uninterrupted supply.