Principal Scientist, Gene Therapy Drug Product Development

Company: Biogen
Location: Cambridge
Posted on: January 12, 2022

Job Description:

Job Description

About This Role

Biogen is accelerating gene therapies that may one day help transform the way we treat neurological diseases. The Principal Scientist, Gene Therapy Drug Product Development will drive process development and technology development as a technical subject-matter expert. You will provide technical leadership within the Gene Therapy Drug Product Department, and across the organization to help establish platforms for gene therapy formulations and fill-finish processes. This includes supporting development, tech transfer and process characterization of AAV portfolio assets moving through development.

What You'll Do

• Lead the design and technical development of gene therapy drug products at any stage of development (preclinical through commercial), support process implementation to manufacturing sites, and author drug product sections to regulatory filings
• Drive technology development and continuous improvement initiatives that anticipate emerging needs in formulations, fill-finish processes, or drug delivery of gene therapies
• Develop manufacturing processes for gene therapy products with an end-to-end view of process control strategy, inclusive of drug substance, drug product and therapeutic delivery
• Lead externally through conferences, publications, and / or consortia engagement
  Who You Are
  
  You build and leverage internal and external networks to drive new capabilities in alignment with business needs, and drive continuous improvement of best practice approaches to drug product development. You have a demonstrated ability to drive novel results, and lead innovation and change.
  
  Qualifications
  
  Education
  
  • Degree in a relevant analytical / scientific / or technical discipline with a Bachelor's degree and minimum of 12 years relevant experience, or a Master's degree and minimum of 10 years relevant experience, or a Ph.D. and minimum of 8 years relevant experience
    Preferred Skills
    
    • Experience developing and commercializating late-stage drug products
    • Experience working with external manufacturing partners
      Required Skills
      
      • Phase-appropriate formulation and process development know-how for large molecule biotherapeutics, vaccine and / or viral drug products
      • Thorough understanding of aseptic fill-finish unit operations; mixing and formulation, sterile filtration, filling, and lyophilization
      • Experience in the development, scale-up, technology transfer, and optimization of aseptic drug product manufacturing processes
      • Experience in late-stage pharmaceutical development activities such as process risk assessments, process characterization, and setting process control strategies
      • Experience with clinical and commercial regulatory filings, and responding to agency queries
      • Use of statistical tools in characterizing and optimizing manufacturing processes
      • Track record of external engagement (publications, presentations, industry consortia involvement, etc)
      • Ability to collaborate and provide leadership in a global cross-functional environment
        Additional Information
        
        • Ability to travel domestically and internationally (Why Biogen?
          
          Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

Keywords: Biogen, Cambridge , Principal Scientist, Gene Therapy Drug Product Development, Healthcare , Cambridge, Massachusetts