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Process Scientist III

Employer
CSL Behring
Location
Holly Springs, North Carolina
Start date
Nov 22, 2022

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Job Details

Job Description

The Opportunity 

You will be part of the Manufacturing Sciences & Technology team at the Holly Springs Influenza Vaccine manufacturing facility, supporting Bulk and/or Fill Finish Operations.  The MS&T function provides strategic technical direction to manufacturing organizations (including 3rd parties) to achieve supply targets and maximize capacity.

Your goals and responsibilities include providing technical expertise related to the process, equipment, and business systems that support Bulk Cell Culture, Fill-Finish, or Technology Transfer teams.   

The Role 

  • Develop depth of knowledge and provides input to other team members on specialist topics to include, but no limited to, extractables and leachables (E&L), nitrosamines, and elemental impurities.

  • Develop technical solutions to complex problems requiring ingenuity and innovative thinking.

  • Leadership, organizational planning and project management skills, and technical expertise in complex biotech systems.

  • Provide mentoring and coaching to internal MS&T and cross-functional resources as applicable.

  • Technical Expert for multiple assigned unit operations, processes, and/or scientific topics in Bulk and/or Fill/Finish Manufacturing operations.  Responsible for the robustness of assigned processes.

  • Troubleshoot and investigate process issues within the manufacturing facility, coordinating with appropriate teams to resolve issues and prevent reoccurrence.

  • Independently lead complex commercial process modifications to improve yield/throughput/capacity, COGs, product quality, process efficiency, and drive work packages to a robust and timely completion.

  • Manage and maintain process monitoring tools (connected to OSI Pi, LIMS, SAP, etc.)

  • Lead complex product and process related investigations and deviations including complaints, Out Of Expectation, Out Of Specification.

  • Offer input to internal and regulatory audits as appropriate, serving as a lead SME during audits.

  • Relay technical information and support training for process-related matters within production to maximize process understanding and enhance knowledge-based decision making.

  • Write and execute Technical Protocols/Studies in support of process characterization, investigations & improvements.

  • Apply scientific and statistical knowledge to analyze data to provide process understanding, and to identify root causes of product and process failures.

  • Contribute to Annual Product Reviews and Product Quality Review for analysis and for contributing to process technology innovations.

  • Author, reviewer, and approver of regulatory license submissions/request for information.

  • Responsible for authoring, maintaining and updating supporting process documentation (Process Descriptions/PRAGA’s) without guidance

Your skills and experience 

  • Minimum 5 years of related pharmaceutical/Biotech industry experience required.  

  • 7+ years of experience preferred.

  • Experience with cell culture manufacturing preferred.

  • Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) required, with direct experience supporting biannual or pre-approval inspections.

  • Must have strong communication skills and good attention to detail.

  • Must be flexible, able to multi-task in a fast-paced environment, and operate well in a team setting.

  • A solid understanding of scientific principles and the ability to apply your knowledge.

  • Advanced troubleshooting skills with ability to mentor others.

  • Excellent organizational, planning and time management skills.

  • The ability to work effectively in both a team environment and an individual contributor role. 

  • Strong Process improvement experience, certification in Lean/Six Sigma preferred

  • Experience and knowledge of statistical software preferred.

  • Advanced knowledge of Excel.

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
US
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