Senior Director CMC Vaccines
Company: CSL Behring
Location: Holly Springs
Posted on: May 14, 2022
Job Description:
Job DescriptionPosition SummaryThis 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
submissionsAbout UsOur BenefitsSeqirus 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 SeqirusSeqirus 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 usAs a global organisation with employees in 35+ countries,
CSL embraces diversity, equity and inclusion. Learn more about
Diversity, Equity & Inclusion at Seqirus.Do work that matters at
Seqirus!
Keywords: CSL Behring, Cary , Senior Director CMC Vaccines, Executive , Holly Springs, North Carolina
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