Senior Research Scientist (Virology)

Company: WuXi AppTec Group
Location: Philadelphia
Posted on: May 27, 2023

Job Description:

Overview
WuXi Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the development and availability of life-saving therapies for patients in need. -
Working at WuXi Advanced Therapies means being part of a dynamic, fast-paced, and innovative environment where you will have the opportunity to work on cutting-edge technology and make a real difference in the lives of patients. Our culture is collaborative and supportive, with a focus on teamwork and continuous learning. -
Our parent company, WuXi AppTec has over 1,800 US-Based employees located with 11 facilities in 8 states. Globally WuXi AppTec spans to more -than 39,000 employees with 32 facilities in 9 countries.
The Senior Research Scieintist is responsible for developing in process and release testing strategiesthat meet federal agency requirements for various internal and external manufacturingprograms for cell and gene therapy products. Lead development and transfer of assaysthat are needed to characterize and release cell and gene therapy products. Thisposition requires continual interaction and collaboration with Clients as well as WuXiAppTec internal departments such as Client Delivery, Testing Operations, QualityAssurance, Process Development, Technology Development, and Manufacturing, inaddition to working with colleagues in Analytical Development.
Responsibilities

• 
  
• Provide guidance to internal and external customers on appropriate testingstrategies and sampling plans for cell and gene therapy clients.
  
• Stay current in the field of cell and gene therapy regulations with respect to bothtesting and manufacturing guidelines.
  
• Serve as a core team member on multiple manufacturing teams and serve as theAnalytical lead. Collaborate with Process Development and client to ensuresampling plans are accurate. Coordinate with Analytical Development subteams,Testing Operations, and Client Delivery to ensure analytical timelines stayon track. Continually communicate accurate timelines to core team leads andproject management.
  
• Experience working with Lentivirus and AAV based vector
  
• Design, conduct and coordinate assay development projects from inception tocompletion for the development of new assays needed to support manufacturingand testing programs.
  
• Conduct critical review of results and report data to management and projectteams. Effectively present detailed data to clients on teleconferences and face toface routinely.
  
• Write research and development reports and ensure all data is representedclearly and accurately.
  
• Author assay qualification and validation protocols and reports.
  
• Prepare and revise technical documents (Laboratory Protocols, SOPs, etc.)
  
• Demonstrate exceptional written and oral communication
  
• Effectively interact with clients to address testing and related questions.
  
• Author risk assessments, as needed.
  
• Completes all required training (i.e. safety, equipment etc.).
  
• Attends scientific conferences, when feasible.
  
  Qualifications
  
  • 
    
  • A PhD in Life Sciences or related field with 5 to 10 years of experience in abiopharmaceutical or biological contract testing/manufacturing organization.
    
  • A BS/MS in Life Sciences 12+ years of experience in a biopharmaceutical orbiological contract testing/manufacturing organization.
    
    Knowledge / Skills / Abilities:
    
    • 
      
    • Thorough knowledge of FDA regulatory guidance documents and EU regulationswith respect to testing requirements for Cell and Gene Therapy products.
      
    • Experience developing and defending testing strategies for biological products.
      
    • Ability to design and develop new assays and direct junior scientists in day to daylaboratory work, as needed.
      
    • Strong oral and written communication skills. Ability to write reports, meetingagendas/minutes, business correspondence, and procedures such as SOPs
      
    • Strong organizational skills with the ability to multi-task and prioritizeassignments
      
    • Excellent critical thinking and problem solving abilities
      
    • Ability to effectively manage multiple projects under short time lines
      
    • Ability to work under pressure and effectively lead in a fast-paced, dynamictechnical environment
      
    • Ability to be flexible and work in cross-functional teams
      
    • A working knowledge of GMP guidelines is required
      
    • Experience with Microsoft Project is a plus
      
      Our Values:
      Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.
      Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.
      WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

Keywords: WuXi AppTec Group, Philadelphia , Senior Research Scientist (Virology), Other , Philadelphia, Pennsylvania