Process Scientist III (Extractables and Leachables)

The Opportunity 

You will be part of the Manufacturing Sciences & Technology team at the Holly Springs Influenza Vaccine manufacturing facility, supporting specialist topics in extractables and leachables (E&L), nitrosamines, and elemental impurities.  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, perform risk assessments, identify/coordinate testing (as applicable), and provide input to other team members on 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.

• Experience with extractables and leachables (E&L), nitrosamines, and elemental impurities.

• 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.

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.

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.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.