Scientist I (Biochemistry)

About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

Job Summary

This Scientist will be responsible for implementing, supporting and maintaining the good R&D practice standards to ensure lab readiness to support GxP regulatory requirements within TD Analytical. Serves as the liaison to work with TD-DEV QA team and provides leadership, in GxP and GLP compliance. Additionally this role would provide analytical assay execution in support of vaccine process and product development programs, e.g. total protein analysis, gel electrophoresis, ELISA for process development or process improvements as needed for the Analytical Biochemistry Team.

Major Accountabilities

Development Work:

• Review and preparation of new and revised Standard Operating Procedures associated with the functions of the Analytical Testing for support of early phase Clinical Trial Material (CTM).
• Perform review of analytical documents, checking for compliance with Good Documentation Practices (GDPs) and Good Laboratory Practices (GLPs)
• Oversee and coordinate analytical laboratory equipment qualification documents.
• Oversees and advises on the development of Standard Operating Procedures, Guidelines and other tools to support early phase CTM testing support.
• Supports the quality and compliance training program; collaborates with operations management to ensure staff training is current as required by their role.
• Works with TD-QA team as liaison to ensure all quality attributes are in place to support GLP testing.
• Work with TD-QA to close gaps related to GLP or GxP lab requirements
• Evaluates procedures and processes affecting quality and proposes process improvements when applicable.
• Experienced and very knowledgeable of FDA, EMA, and other regulatory regulations.
• Experienced in managing concurrent complex projects/programs (e.g. process improvement initiatives for lab).
• Proactively identify development and improvement opportunities
• Able to work under tight deadlines.
• Functions effectively as core team member on multiple concurrent projects and leads small projects and establishes work processes.
• As required, provide analytical assay execution in support of vaccine process and product development programs, e.g. total protein analysis, gel electrophoresis, ELISA for process development or process improvements.
• Data collection and reporting with knowledge of GLP/GMP environments.
• Work closely with the Separation, Biochemistry, and Molecular and Cellular Biology groups within TD-Analytical to provide technical expertise for GLP/GxP requirements or lab support for process improvements or assay development support.
• Provide support on reviewing documentation in notebooks and reviewing data in LIMS for specific lab based processes that the employee is trained on.
• Interface with electronic business systems (e.g, LIMS, SAP, EDMS)

Operations/Quality Support:

-Serves as interface between TD and Operations, and represents TD department in cross-functional forums to support manufacturing and QC

-Utilizes knowledge and experience with analytical techniques used in biopharmaceutical (i.e., vaccines) process development and GMP manufacturing

-Uses scientific and statistical knowledge to support product, process and testing related investigations and deviations including complaint, deviation, OOE and OOS investigations that require support for development work

-Generates a supportive business case, and supports cross-functional teams to deliver those opportunities

People Management:

- Provides guidance to new team members, interns and students and acts as a resource for colleagues with less experience

Minimum Requirements

• Experience with analysis of proteins and/or RNAs is highly desired for support of Analytical Lab Development and assay improvements
• Must be knowledgeable in R&D compliant quality systems and have experience with FDA, EMA, and other regulatory regulations.
• Excellent communication skills including: technical writing skills, PC skills, and critical thinking and analysis.
• Experience with FDA, EMA, and other regulatory regulations as required.
• Experience in managing concurrent complex projects/programs (e.g. process improvement initiatives, clinical projects).
• Ability to work effectively in a team environment and with individuals at all levels within an organization.
• Ability to manage concurrent complex projects/programs.
• Provides technical advice on issues within own discipline
• Demonstrated Lominger competencies in ethics and values, integrity and trust, decision quality, functional/technical skills, peer relationships, perseverance and problem solving
• Experience in biopharmaceutical analytical development is desirable
• Effective delivery of objectives in a complex matrix environment and effective verbal & written communication skills in a cross functional environment
• Proactively owns and drives assigned tasks to completion
• Ability to present solutions to complex and strategic issues
• Evidence of commercial awareness in technical strategies
• Excellent customer focus with demonstrated management of customer expectation
• Excellent presentation skills
• Bachelor's Degree or Master's Degree or PhD in related scientific field
• 8+ years with BS, 5+ years with MS or 0-4 years with PhD