Sr. Scientist (Process Development / mRNA)

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 Summary:

The individual provides leadership for a team of scientific staff and serves as a subject matter expert responsible for oversight of development, scale-up, tech transfer and manufacture of mRNA vaccines for pre-clinical and clinical studies. Supports projects that will drive future growth through process improvements.  Uses scientific and GLP/GMP knowledge to ensure compliance with company and regulatory agency guidelines as it relates to equipment, materials, facilities, and process development, scale-up and manufacture.

Major Responsibilities:

Process and Product Development:

• Represents Technical Development and interphases with MS&T and Operations to scale-up and tech transfer processes for the manufacture of seasonal and pandemic mRNA vaccines.
• Guides development and scale-up of complex processes and communicates risk-based assessments and recommendations to key stake holders.
• Leads TD mRNA vaccine scientific team responsible for development, scale-up, and manufacture of pre-clinical and clinical material.
• Represent TD on cross-functional teams related to mRNA-based vaccine program.
• Proactively identifies development and improvement opportunities, generates a supportive business case, and supports cross-functional teams to deliver those opportunities.
• Uses a data driven approach to progress development deliverables.
• Responsible for using scientific and GLP/GMP knowledge to support site and global mRNA vaccine projects.

People Management:

• Direct supervisor for a team of 4-6.
• Provides ongoing performance feedback to direct reports.
• Provides scientific/technical guidance and mentorship to TD mRNA Process team.
• Models a culture of safety, ensures team adheres to requirements, and identifies and implements improvements.
• Maintains a state of compliance for team through regular review of training and implementing training curricula improvements.
• Serves as subject matter expert and general scientific resource for colleagues with less experience.

Operations/Quality Support:

• Serves as interface between TD and MS&T/Operations by representing TD department in cross-functional forums and informing stakeholder of key information to support the scale-up, tech transfer, and manufacture of pre-clinical and clinical material.
• Utilizes knowledge and experience of GLP/GMP as well as mRNA vaccines to provide technical support for development and manufacture of drug substance and drug product.
• Uses scientific and statistical knowledge to support product, process and testing related investigations and deviations.

Other:

• Generates data summaries and presents project progress for internal audiences and key stakeholders in other groups (Operations, MS&T, QA, QC). 
• Completes all individual training and maintains a state of compliance.
• Adheres to all safety requirements.

Minimum Requirements:

• B.S., M.S. or PhD in related scientific field with 7+ years relevant industry experience
• Requires in-depth conceptual and practical expertise in own technical or scientific discipline (focus on vaccines, more specifically mRNA vaccines).
• Technical expertise in mRNA synthesis, lipid nanoparticle (LNP) formulation required.
• Experience with GLP and GMP compliance and manufacturing required.
• Ability to present solutions to complex and strategic issues in a complex matrix environment.
• Experience writing content for technical documentation including SOPs, work instructions, technical protocols and reports, and technical presentations.
• Ability to quickly respond to rapidly changing priorities.
• Flexible and adaptable attitude with the ability to support change management.
• Strong attention to detail.
• Effective verbal & written communication skills in a cross functional environment.
• Experience presenting complex technical concepts to a wide range of audiences of varying technical depth.