CMC Lead Gene Therapy

Employer
CSL Behring
Location
King of Prussia, Pennsylvania
Posted
Sep 15, 2020
Ref
R-121878
Hotbed
Pharm Country
Required Education
Doctorate/PHD/MD
Position Type
Full time
About CSL

With operations in 35+ nations and ~ 22,000 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 the second largest influenza vaccine company 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 Summary:


  • This role will lead a project-specific CMC team(s) within CSL Behring's Gene Therapy Product pipeline. The primary responsibility is to ensure a consistent, rigorous and compliant approach to development and regulatory submissions is applied. To accomplish this objective, the CMC Lead will provide direction, guidance, coordination and oversight to a cross-functional, global CMC team.

    This is a senior leadership role within CSL Behring Recombinant and Gene Process Development R&D, with responsibilities to intimately manage the CMC Team, ensuring goals are set, progress is formally measured and the requirements of the Project are met in terms of quality, cost and timeliness.

    Job Responsibilities:
    • Responsible for strategy development, planning and timely implementation for all CMC related aspects to drive the assigned development project by leading a global CMC team.
    • Specific aspects of the CMC team include manufacturing of drug substance/drug product (and device incorporation where applicable), quality, regulatory, manufacturing operations related aspects as well as supply chain.
    • As a team member of the Core Project Team he/she is accountable for CMC & associated readiness activities, the CMC lead will represent product development and contribute to project strategies.
    • He/she provides consolidated recommendations to the Core Project Team and assures appropriate actions within the CMC functions are executed in alignment with project goals
    • Responsible for leading development/revision of the Quality Target Product Profile (QTPP) according to the current TPP.
    • Responsible for defining CQA/CMA via generally recognized risk assessment methodologies
    • Responsible for product and process risk assessment and parameter criticality determination
    • Responsible for establishment and documentation of process control strategies
    • Responsible for CMC elements of regulatory submissions and consultations. Evaluates CMC risks and appropriately escalates to Project Strategy Group (PSG) 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.
    • Responsible for implementation of CMC deliverables within budget considering external and internal costs.


    Qualifications


    • PhD or MSc in Biochemistry/Biology strongly preferred.
    • Minimum 10 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/collaborators.
    • 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
    • Fluent in English


    Travel - 20-25%, domestic and international