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Manager MS&T Technical Services Fill – Finish

Employer
CSL Behring
Location
Holly Springs, North Carolina
Start date
Oct 1, 2022
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Job Details

Job Description

The Opportunity

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

The Role

  • 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.

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!

Company

As the third largest global biotechnology company with employees in more than 35 countries, CSL Behring is focused on serving patients with serious and rare diseases, including coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease and neurological disorders. We collaborate with patient and biomedical communities to improve access to therapies, advance scientific knowledge and support future medical research. 


CSL Behring's dynamic environment fosters innovation and attracts the best and brightest who share a commitment to helping save lives. People here are free to live their Promising FUTURES where they can fulfill their individual career aspirations and realize their potential. 


CSL Behring is committed to diversity and inclusion, both of which underpin our Values of patient focus, innovation, collaboration, integrity and superior performance. We believe that by harnessing and honoring the unique capabilities, experiences and perspectives of our people, we are better able to serve our patients.


CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited, headquartered in Melbourne, Australia, employs more than 27,000 people, and provides its life-saving medicines in more than 70 countries. 
For more information visit www.cslbehring.com. Help us deliver on our promise to save lives and protect the health of people around the world. Promising FUTURES start at CSL Behring!

Stock Symbol: CSL

Stock Exchange: Australian Securities Exchange

Find Us
Phone
610-878-4000
Location
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States
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