Reporting to the Director MS&T, you will direct a team of 5+ MS&T Process Scientists/Engineers and contractors. This role will offer you the opportunity to oversee the commercial operations for Drug Product with potential support required for third-party/cross-network manufacturing, and ongoing and future facility expansions. As the Manager MS&T Technical Services Fill-Finish, you will ensure there is a depth of process knowledge embedded within the Technical Services Team in order to maintain continuity in the level of service provided to the manufacturing teams and other reliant functions. You will support commercial manufacturing and drive continuous improvements into the Fill-Finish Manufacturing Processes. Seqirus operates in a global network. The holder of the position will work with the MS&T organizations at the other Seqirus production sites to maintain a common shared vision, scientific direction and work
Lead and align the Fill-Finish Tech Services team
Ensure swift resolution of manufacturing process issues.
Accurate root cause diagnosis for investigations, understanding and prioritization of optimization projects through Suite Teams.
Lead important deviation investigations and implement CAPA's
Lead product process-related investigations including complex customer complaints, OOT, OOS.
Investigate and resolve recurring process capability deviations and issues that emerge from data trending and annual batch monitoring.
Ensure that investigation outcome are shared across the global Seqirus network.
Manage technical documentation relating to the Fill-Finish manufacturing processes including PRAGA, Process Descriptions, Sampling Plans.
Subject matter experts on the execution of Fill-Finish processes and the science and technologies that support the procedures.
Train for process-related matters within production to maximize process understanding and to enhance knowledge-based decision-making.
Support internal and external inspections and audits.
Author and approve regulatory submission sections.
Your skills and experience
Bachelor's degree in Biology/chemical engineering, chemistry, microbiology or cell engineering or equivalent is required.
Minimum 10+ years' relevant industry experience required.
Demonstrated knowledge of GMPs and FDA requirements
Project management skills
Benefits: Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day of hire.
Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.
Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.
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