Senior Scientist - HPLC - QC

Company: Thermo Fisher Scientific Inc.
Location: Boston
Posted on: May 24, 2025

Job Description:

Work Schedule
First Shift (Days)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) and Safety Standards
Job Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. Our work spans laboratory, digital, and decentralized clinical trial services, with clinical trials conducted in over 100 countries and ongoing development of novel frameworks for clinical research through our PPD portfolio. Your dedication to delivering quality and accuracy will help improve health outcomes for people and communities now and in the future.
Thermo Fisher's clinical research division is a leading global contract research organization and a world leader in serving science. We are passionate, deliberate, and driven by our mission to enable our customers to make the world healthier, safer, and cleaner.
Within our Analytical Services team, we offer a unique partnership solution that allows our customers to leverage our staff's experience while providing employees with the opportunity to work onsite at pharmaceutical or biopharmaceutical companies, maintaining full benefits.
Key Responsibilities:

• 
  
• HPLC experience is a MUST HAVE
  
• Small Molecule experience is a MUST HAVE
  
• Perform laboratory activities to meet commitments on time
  
• Conduct in-process, release, and stability testing following established methodologies, procedures, and SOPs
  
• Maintain accurate testing records and adhere to cGMP/GDP standards
  
• Participate in planning, executing, or reviewing method validations and transfers
  
• Troubleshoot analytical methods as needed
  
• Lead OOT/OOS investigations, deviations, and identify corrective actions to prevent reoccurrence
  
• Perform other laboratory duties as assigned
  
• Author, review, and approve data, SOPs, methods, protocols, and reports
  
• Participate in compliance teams focused on continuous improvement
  
• Serve as CQC representative in cross-functional teams or with outside vendors to meet laboratory needs
  
  Education and Experience:
  
  • 
    
  • Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology, or related fields
    
  • Senior Scientist: Typically requires 4+ years of relevant experience
    
  • OR Master's degree with approximately 2+ years of experience
    
  • OR PhD
    
    Equivalent combinations of education, training, and experience may be considered.
    Knowledge, Skills, and Abilities:
    
    • 
      
    • Strong knowledge of cGMP in a pharmaceutical setting
      
    • Proficiency in analytical techniques such as HPLC, dissolution, GC, KF, etc., including method validation and transfer
      
    • Experience with both drug substance and drug product testing (oral solid dosage forms)
      
    • Attention to detail
      
    • Effective communication skills, both verbal and written
      
      Working Environment:
      The role requires:
      
      • 
        
      • Ability to communicate effectively with diverse groups
        
      • Ability to work upright, stationary, or standing for typical hours
        
      • Ability to lift and move objects up to 25 pounds
        
      • Ability to work in non-traditional environments
        
      • Proficiency with standard office equipment and technology
        
      • Potential exposure to hazardous elements, including infectious agents
        
      • Ability to perform under pressure, managing multiple projects
        
        Note: Employment requires proof of COVID-19 vaccination.
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Keywords: Thermo Fisher Scientific Inc., Taunton , Senior Scientist - HPLC - QC, Other , Boston, Massachusetts