Manager MS&T Technical Services Secondary Fill - Finish
The Manager of MS&T Secondary Fill-Finish Technical Services will direct a team of 5
MS&T Process Scientists/Engineers and contractors. Direct functional responsibility includes commercial operations for Secondary Drug Product with potential support required for third-party/cross-network manufacturing, and ongoing and future facility expansions. The Manager MS&T Technical Services Secondary 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 Secondary 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 The Role You will:
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 Secondary 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. About Us Our Benefits 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. About 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 . We want Seqirus to reflect the world around us As a global organisation with employees in 35
countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus. Do work that matters at Seqirus!
Salary Range:
$150K -- $200K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
MS&T Process Scientists/Engineers and contractors. Direct functional responsibility includes commercial operations for Secondary Drug Product with potential support required for third-party/cross-network manufacturing, and ongoing and future facility expansions. The Manager MS&T Technical Services Secondary 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 Secondary 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 The Role You will:
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 Secondary 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. About Us Our Benefits 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. About 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 . We want Seqirus to reflect the world around us As a global organisation with employees in 35
countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus. Do work that matters at Seqirus!
Salary Range:
$150K -- $200K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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