The Process Scientist provides technical support to the Manufacturing and Quality organizations. You will partner closely with Technical Experts and Regulatory on introduction and integration of new products, processes and formulations.
Act as a Subject Matter Expert on the production of a cellular immunotherapy by providing technical support to address real-time process deviations.
May be asked to provide 24/7 support for both routine and complex deviations.
Provide timely process and product impact assessments to support Quality product disposition decisions.
Participate in investigations to identify contributing root cause for product failures and process deviations using a variety of tools including (but not limited to) review of primary data, technical reports, patient history, trending reports and regulatory information.
Author technical documents for investigations for inclusion in GMP documentation.
May generate protocols and reports to support process improvement and process validation activities at the IMF.
Assists with technical transfer activities for processes being transferred to or from the IMF.
May work on cross-functional project teams to assess the scientific, regulatory, and business impact of process improvement initiatives.
May assist in the management and implementation of approved process improvement projects at the IMF and contract manufacturing facilities.
May author, own, or assess change controls related to changes to processes at IMFs and contract manufacturing facilities.
Participates in regulatory inspections as needed.
Strong communication (verbal and written) and organizational skills required.
Minimum of bachelor’s degree in a scientific discipline or equivalent.
Minimum of 5 year related experience in cGMP/FDA regulated industry.
Understanding of statistical analysis of data sets.
Understanding of Risk Management principles.
Experience with analyzing data from methods, such as ELISA and Flow Cytometry.