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Senior Director CMC Vaccines

Employer
CSL Behring
Location
Holly Springs, North Carolina
Start date
Sep 25, 2022

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Discipline
Science/R&D, CMC
Required Education
Masters Degree/MBA
Position Type
Full time

Job Details

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

About Us

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 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!

Company

As the third largest global biotechnology company with employees in more than 35 countries, CSL Behring is focused on serving patients with serious and rare diseases, including coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease and neurological disorders. We collaborate with patient and biomedical communities to improve access to therapies, advance scientific knowledge and support future medical research. 


CSL Behring's dynamic environment fosters innovation and attracts the best and brightest who share a commitment to helping save lives. People here are free to live their Promising FUTURES where they can fulfill their individual career aspirations and realize their potential. 


CSL Behring is committed to diversity and inclusion, both of which underpin our Values of patient focus, innovation, collaboration, integrity and superior performance. We believe that by harnessing and honoring the unique capabilities, experiences and perspectives of our people, we are better able to serve our patients.


CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited, headquartered in Melbourne, Australia, employs more than 27,000 people, and provides its life-saving medicines in more than 70 countries. 
For more information visit www.cslbehring.com. Help us deliver on our promise to save lives and protect the health of people around the world. Promising FUTURES start at CSL Behring!

Stock Symbol: CSL

Stock Exchange: Australian Securities Exchange

Company info
Phone
610-878-4000
Location
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States

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