Position Summary: Oversees the management of Downstream Manufacturing floor operations (Protein capture through Bulk Filtration) and related Specialist support teams to manufacture GMP drug substance while driving a safe and compliant production environment through structured on-floor presence.
Ensures schedule adherence for tasks including but not limited to manufacturing, qualification, and maintenance activities.
Actively participate as a role model in Lean culture and continuous improvement programs with responsibility to translate onto the manufacturing floor.
Staff selection, training, oversight, performance evaluations, and development.
Ensures standard operating procedures are accurate for executing unit operations, batch record review & MRP transactions are completed accurately meeting disposition timelines, trend and track departmental metrics, and non-conformances are initiated and closed with right the first-time documentation.
Reviews technical documents, change controls, solution records and batch records for accuracy, thoroughness and regulatory compliance.
Utilizes leadership and technical expertise to make real time processing decisions, monitors processes and equipment.
Troubleshoot and perform initial assessment of events that have the potential to impact area safety and product quality.
Assists area manager with the implementation of long and short-range plans, policies, programs and objectives.
Identifies, recommends and implements changes to improve productivity and reduce cost and waste.
This proven and qualified candidate will serve as a subject matter expert (SME) as required during regulatory inspections for deviations, change controls, and process documentation. Make decisions as a SME on mammalian large scale production processes especially for chromatography and tangential flow filtration.
Perform miscellaneous duties and projects as assigned and required.
Plan, schedule, and support long and short-range plans, production tasks to ensure schedule adherence.
Facilitate additional manufacturing activities and process support with other manufacturing groups, MS&T and PD, QA, Maintenance and Engineering, and AFS and Microbiology.
Supervise, coach, mentor and train team members to maintain educated, qualified and motivated employees. Ensure staff maintain a high level of compliance to procedures and quality expectations.
Ensure timely execution and review of batch documentation and logbooks, initiation of deviations, and execution and completion of ERP orders. Ensure timely corrections to batch documentation and logbooks.
Drive process improvement initiatives, troubleshoot issues, trend and track metrics and author, review and approve procedures, deviations, CAPAs, and change controls as needed.
Ensure equipment and manufacturing facilities remain in working order by overseeing production technician maintenance, cleaning, and ensuring timely submission of work orders for facility and equipment maintenance and repair.
Bachelor's Degree in Chemical / Biochemical / Biological Engineering or related discipline with 10+ years of experience in a GLP, GMP and/or ICH/GCP environment or equivalent experience considered.
4+ years of experience leading a team, managing others directly or indirectly.
Mechanical ability/expertise coupled with a solid technical background of purification processes and equipment, strong knowledge of GMP practices preferred.
Experience in single-use platform technology is preferred.
Excellent organization, technical writing and communication skills.
Energetic and motivated individual with the ability to multi-task and meet aggressive deadlines for clinical and commercial production.
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