Lead a team to manage all activities to ensure that manufacturing processes are supported. Responsible to support the Process Sciences Department through Process Validation, manufacturing floor support, product impact assessments, investigations, and technical evaluation as required. Active member of the Process Sciences management team.
• Lead a team and manage all activities to assure that manufacturing processes are supported.
• Responsible for developing a team such as development plans, upskilling and team forming.
• Write, review and approve Process Validation protocols and reports.
• Identification of process parameters and appropriate ranges to be included in process validation.
• Provide on the floor support to Manufacturing (Cell culture and Purification.)
• Lead/Participate Process and Quality risk assessments.
• Lead troubleshooting activities associated with the manufacturing process.
• Provide technical support for manufacturing personnel to improve understanding of both cell culture and purification operations.
• Review and approve manufacturing documentation such as manufacturing records, SOPs and batch sheets.
• Develops/writes/plans and reviews protocols and activities for manufacturing support.
• Serves as a subject matter expert (SME) for data trending and manufacturing support.
• Presents and reviews process monitoring data to IOPS Management as necessary.
• Investigates and reviews OOS and OOL IPCs investigations.
• Performs, reviews and approves product impact assessment.
• Performs, reviews and approves scientific investigations (EOE & DNF.)
• Communicate information on current process data and other IOPS initiatives which may impact process development and/or technology transfer.
• Support the site through regulatory audits by providing technical expertise.
• Work efficiently and effectively in a fast-paced team-oriented environment to ensure maximum and high-quality output.
• BS/BA in a related field.
• 6+ years of related experience in a GMP environment.
• Previous experience in biological drug substance (DS) manufacturing.
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