Senior Director, CMC Cell and Gene Therapy

Employer
CSL Behring
Location
King of Prussia, Pennsylvania
Posted
Jan 13, 2021
Ref
R-121878
Hotbed
Pharm Country
Required Education
Doctorate/PHD/MD
Position Type
Full time
About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

Job Overview:

This role will lead a team of Director level CMC leads concentrating on CSL Behring's cell and gene therapy 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, Cell and Gene Therapy will provide strategic direction, guidance, coordination and oversight to project specific CMC team leaders and teams.

This is a senior leadership role within CSL Behring's Recombinant and Gene Product Development (RGPD) team, 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.

Reporting Structure:
  • This role reports into the Executive Director CMC, Recombinant and Gene Product Development.
  • Positions reporting to are:
    • Director, CMC Lead (2 positions currently)


Key Deliverables:

Portfolio Responsibilities Include:
  • Show scientific and technical leadership to staff by establish overarching CMC strategies for development of CGT products through all stages of development up to and including BLA/MAA preparation and drafting.
  • Expand CSLs CGT knowledge base as it pertains to cell and gene therapy product development, characterization and licensure following Quality by Design principles.
  • Oversee and review progress of departmental activities against project timelines.
  • Ensure RGPD 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 the resources and leadership to support the regulatory submissions of our CGT portfolio.
  • Provide strategic guidance for future planning requirements for Product Development.
  • 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 developing CGT products.


Product specific Responsibilities Include:
  • Strategy development, planning and timely implementation for all CMC related aspects associated with CSL's Lead late stage CGT asset
  • Lead product development, utilizing both internal and external resources, for drug substance/drug product, quality, regulatory, manufacturing operations related aspects as well as supply chain.
  • As a team member of the Project Strategy Team he/she is accountable for CMC & associated readiness activities, the CMC lead will represent product development and contribute to project strategies.
  • Provides consolidated recommendations to the Project Strategy Team and assures 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

  • PhD or MSc in Biochemistry/Biology, BE or minimum 7 years' experience.
  • Extensive experience in biotechnological development of therapeutic proteins
  • Experience in scale-up of the expression, purification, formulation and testing of recombinant Viral Vectors and/or Cellular Therapeutics.
  • Experience in working with external companies
  • Hands-on recent experience in validation and characterization studies for the registration of Viral vector, cell based therapeutics or recombinant proteins
  • Experience in authoring sections within Regulatory submissions
  • Must be independent and capable of working for extended periods without supervision
  • Must be able to deal with rapid change, have a strong customer service focus, be committed to high quality outcomes
  • Must have excellent and proven people management, communication and presentation skills
  • Must have experience in managing complex cross-cultural communication between teams
  • Have resource planning, scheduling and budgeting skills
  • Technical/scientific protocol and report writing
  • Computer literate
  • Have a detailed understanding of GLP, GMP, process validation and scale up parameters
  • Have a detailed technical background in the scale-up of the expression, purification, formulation and testing of recombinant proteins
  • Fluent in English