CMC Lead (Vaccines)

This role is responsible for leading project-specific Chemistry, Manufacturing and Control (CMC) matrix teams. The primary responsibility and accountability of the role is to define and deliver contemporary CMC packages during clinical development, market authorization, and Life Cycle Management (LCM). During early clinical development, the CMC Lead defines the manufacturing plan and ensures clinical supply. The role provides technical guidance, operational coordination, and cross-functional leadership within and across Integrated Project Teams (IPTs), aligning CMC activities with program objectives.

RESPONSIBILITIES AND ACCOUNTABILITIES

List the essential job duties and responsibilities in order of priority or time spent on each.  Include only those items that are the sole or primary reason the job exists, items that require specialized skills or training, and items that demand a significant portion of time to perform (Do not list competencies, education, training requirements, etc.).

• Lead CMC project teams for assigned programs, ensuring execution of process, analytical, and manufacturing plans to meet development milestones

• Define and deliver phase-appropriate control strategies, including contributing to product specifications in collaboration with technical subject matter experts.

• Support authoring and review of CMC sections for regulatory submissions, applying established regulatory guidance and basic QbD principles

• Accountable for delivery of the Quality Section during clinical development, market authorization, and LCM changes

• Maintain line-of-sight to manufacturing delivery (contracts, production, validation, regulatory activities) in collaboration with sites and partners

• Ensure effective communication of CMC strategies, objectives, and progress within project teams, IPTs, and relevant stakeholders

• Accountable for CMC/QbD related project and product documentation (for example: risk assessments, PFMEAs, monitoring strategies) in accordance with relevant policies

• Collaborates across IPTs to assure alignment and continuous improvement on best practices for QbD and CMC development

Education

• Bachelor’s degree in a relevant scientific or technical field (e.g., Biochemistry, Pharmaceutical Sciences, Chemical or Biomedical Engineering, Biotechnology, Biology/Chemistry, etc.)
• Advanced degree (MS or PhD) in a related field strongly preferred

Experience

• 10+years of experience in pharmaceutical industry with emphasis on manufacturing operations, process design, and process validation
• Demonstrated experience in project management and/or leadership by influence preferred
• Advanced knowledge of biological manufacturing processes and advanced CMC/QbD requirements for plasma derived or biotechnology therapies is preferred
• Technical and regulatory writing experience
• Previous experience working across sites and as part of international teams is highly desirable
• Track records in leading teams is crucial to perform in this role

Competencies (Measurable or observable skills, abilities, and behaviors critical to successful job performance.)

• Fluent in English
• Strong problem-solving capabilities with a proactive, solution-oriented approach
• Deep knowledge of CMC principles, lifecycle management strategies, and regulatory requirements such as ICH guidelines
• Strong matrix leadership and program management skills with the ability to maintain strategic focus over long project timelines

Working Conditions

(Physical & mental requirements.)

• Requires sustained focus and engagement over extended project timelines
• Ability to manage multiple priorities and navigate complex matrixed environments
• May involve significant periods of on-site presence at manufacturing or partnering organizations and CDMO locations during key phases

Travel Requirements (Domestic, International, frequency)

• Periodic travel for project-related activities (frequency and locations dependent to be further defined)

About CSL Seqirus

CSL Seqirus is part of 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. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

 To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.

Watch our ‘On the Front Line’ video to learn more about CSL Seqirus