Reporting to the Director MS&T:
The Manager of MS&T Fill-Finish Technical Services will direct a team of 5+ MS&T Process Scientists/Engineers and contractors. Direct functional responsibility includes commercial operations for Drug Product with potential support required for third-party/cross-network manufacturing, and ongoing and future facility expansions. The Manager MS&T Technical Services Fill-Finish will ensure there is a depth of process knowledge embedded within the Technical Services Team such to maintain continuity in the level of service provided to the manufacturing teams and other reliant functions. You will support commercial manufacture 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,
* 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 investigations outcomes 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 for
* 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.
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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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Do work that matters at Seqirus!
- Chemical Engineering
- Decision Making
- Project Management