Senior Director CMC Vaccines
Company: Seqirus
Location: Holly Springs
Posted on: August 7, 2022
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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
Keywords: Seqirus, Cary , Senior Director CMC Vaccines, Executive , Holly Springs, North Carolina
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