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 AccountabilitiesList 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 milestonesDefine 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 principlesAccountable for delivery of the Quality Section during clinical development, market authorization, and LCM changesMaintain line-of-sight to manufacturing delivery (contracts, production, validation, regulatory activities) in collaboration with sites and partnersEnsure effective communication of CMC strategies, objectives, and progress within project teams, IPTs, and relevant stakeholdersAccountable for CMC/QbD related project and product documentation (for example: risk assessments, PFMEAs, monitoring strategies) in accordance with relevant policiesCollaborates across IPTs to assure alignment and continuous improvement on best practices for QbD and CMC developmentEducation 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 preferredExperience10+years of experience in pharmaceutical industry with emphasis on manufacturing operations, process design, and process validationDemonstrated experience in project management and/or leadership by influence preferredAdvanced knowledge of biological manufacturing processes and advanced CMC/QbD requirements for plasma derived or biotechnology therapies is preferredTechnical and regulatory writing experiencePrevious experience working across sites and as part of international teams is highly desirableTrack records in leading teams is crucial to perform in this roleCompetencies (Measurable or observable skills, abilities, and behaviors critical to successful job performance.)Fluent in EnglishStrong problem-solving capabilities with a proactive, solution-oriented approachDeep knowledge of CMC principles, lifecycle management strategies, and regulatory requirements such as ICH guidelinesStrong matrix leadership and program management skills with the ability to maintain strategic focus over long project timelinesWorking Conditions(Physical & mental requirements.)Requires sustained focus and engagement over extended project timelinesAbility to manage multiple priorities and navigate complex matrixed environmentsMay involve significant periods of on-site presence at manufacturing or partnering organizations and CDMO locations during key phasesTravel Requirements (Domestic, International, frequency) Periodic travel for project-related activities (frequency and locations dependent to be further defined)About CSL SeqirusCSL 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 BenefitsFor more information on CSL benefits visit How CSL Supports Your Well-being | CSL.You Belong at CSLAt 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-belongingEqual Opportunity EmployerCSL 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