Senior Director CMC Vaccines

Company: Seqirus
Location: Holly Springs
Posted on: August 7, 2022

Job Description:

Job Description Position Summary This role will lead a team of Director level CMC leads concentrating on the CSL Vaccine product portfolio. The primary responsibility is to ensure consistent, rigorous, and compliant approaches are implemented from product development for clinical studies through regulatory submissions. To accomplish this objective, the Senior Director CMC, Vaccine products will provide strategic direction, guidance, coordination and oversight to project specific CMC team leaders and teams. This is a senior leadership role within Product Development, with responsibilities to intimately manage CMC Team activities, ensuring goals are set, progress is formally measured, and project requirements are met in terms of quality, cost, and timeliness. Main Responsibilities and Accountabilities: - Oversee and review progress of departmental activities against project timelines Show scientific and technical leadership to staff by establish overarching CMC strategies for development of recombinant products through all stages of development up to and including BLA/MAA preparation and drafting. Expand CSLs knowledge base as it pertains to product development, characterization and licensure following Quality by Design principles. Oversee and review progress of departmental activities against project timelines. Ensure Product Development provides accurate leadership to project strategic planning committees regarding product targets (e.g. purity, yield) and developmental stages in terms of budgets, timing, industry standards and technology. Provide strategic guidance for future planning requirements for RGVPD. Perform Due Diligence assessments of new technology opportunities, new partnership opportunities and new acquisition opportunities as required. Maintain up to date knowledge of global standards, international quality systems and best practices for biotech products. Lead and motivate all staff within the departments Identify and train a new leadership within the departments Provide consolidated recommendations to the Project Strategy Team and assure appropriate actions within the CMC development functions are executed in alignment with project goals Responsible for CMC elements of regulatory submissions and consultations. Evaluates CMC risks and appropriately escalates as appropriate and proactively provides mitigation plans. Provides timely feedback and communicates information to stakeholders and, in case of scientific/technical issues, coordinates correctives measures across functions in cooperation with local department heads & global functions as needed and ensure appropriate reporting. Qualifications and Experience: - PhD or MSc in Biochemistry/Biology or minimum 10 years--- experience. Extensive experience in biotechnological development of Vaccines, Viral vectors, cell-based therapeutics and/or recombinant proteins Experience in process scale-up and tech transfer of the expression, purification, formulation and testing of therapeutic products. Hands-on recent experience in validation and characterization studies for the registration of Vaccines, Viral vector, cell-based therapeutics or recombinant proteins Experience in authoring sections within Regulatory submissions Our Benefits 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 Seqirus. About Seqirus Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus. We want 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 Seqirus. Do work that matters at Seqirus Watch our ---On the Front Line--- video to learn more about Seqirus

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