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
Develops technical solutions to complex problems requiring ingenuity and innovative thinking related to support of commercial implementation of new drug products.
Strong leadership, organizational planning and project management skills, and technical expertise in complex biotech systems.
Provides 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.
Troubleshoots and investigates process issues within the manufacturing facility, coordinating with appropriate teams to resolve issues and prevent reoccurrence.
Independently leads complex commercial process modifications to improve yield/throughput/capacity, COGs, product quality, process efficiency, and drives work packages to a robust and timely completion.
Manages and maintains process monitoring tools (connected to OSI Pi, LIMS, SAP, etc.)
Leads complex product and process-related investigations and deviations including complaints, Out of Expectation, and Out of Specification.
Provides input to internal and regulatory audits as appropriate, serving as a lead SME during audits.
Provides technical information and support training for process-related matters within production to maximize process understanding and enhance knowledge-based decision-making.
Writes and executes Technical Protocols/Studies in support of process characterization, investigations & improvements.
Uses scientific and statistical knowledge to analyze data to provide process understanding, and to identify root causes of product and process failures.
Contributes to Annual Product Reviews and Product Quality Reviews 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 the 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
CSL 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 CSL Seqirus.
About CSL Seqirus
CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL Seqirus.
We want CSL Seqirus to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus.
Do work that matters at CSL Seqirus!
Watch our ‘On the Front Line’ video to learn more about CSL Seqirus
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