PSC Biotech Jobs Hiring Now

• Lead formulation assessment and process transfer activities from client organizations.
  
• Review development reports, formulation histories, and manufacturing records.
  
• Support development and optimization of sterile injectable formulations.
  
• Evaluate formulation robustness, manufacturability, and scale-up risks.
  
• Develop formulation and process transfer documentation.
  
• Collaborate with clients to establish manufacturing strategies for clinical and commercial production
  

• • Develop and optimize compounding processes for sterile drug products.
    
  • Establish mixing strategies, hold times, filtration approaches, and process parameters.
    
  • Support formulation scale-up from laboratory to GMP manufacturing.
    
  • Identify critical process parameters (CPPs) and critical quality attributes (CQAs).
    
  • Author process descriptions and manufacturing instructions.
    
  • Evaluate process performance and support continuous improvement initiatives.
    

• Provide technical support during:
  
• • Solution preparation
    
  • Compounding operations
    
  • Sterile filtration
    
  • Aseptic filling
    
  • Lyophilized product manufacturing
    
• Support engineering runs and manufacturing campaigns.
  
• Troubleshoot processing deviations and formulation-related challenges.
  
• Investigate batch failures, yield losses, or process excursions.
  

• Design and execute process characterization studies.
  
• Support:
  
• • Mixing studies
    
  • Hold time studies
    
  • Filtration studies
    
  • Product recovery studies
    
  • Process robustness evaluations
    
• Evaluate manufacturing scalability and process capability.
  
• Generate data supporting process validation and commercialization.
  

• Serve as technical SME during client onboarding and transfer activities.
  
• Support preparation of:
  
• • Technology Transfer Plans
    
  • Gap Assessments
    
  • Risk Assessments
    
  • Process Transfer Reports
    
• Participate in client meetings and technical reviews.
  
• Provide scientific guidance throughout development and manufacturing campaigns.
  

• Support formulation development for lyophilized products.
  
• Collaborate with Lyophilization Development teams on:
  
• • Formulation optimization
    
  • Reconstitution performance
    
  • Product stability considerations
    
• Support cycle transfer and scale-up activities.
  

• Ensure activities comply with:
  
• • FDA cGMP requirements
    
  • EU GMP Annex 1
    
  • ICH Guidelines
    
  • USP Standards
    
• Support investigation activities, CAPAs, and client audits.
  
• Provide technical documentation for regulatory submissions when required.

Requirements

• Bachelor of Science in: Chemical Engineering, Pharmaceutical Sciences, Biochemistry, Biotechnology, Related discipline
  
• 4-7 years of experience in:
  
• • Sterile formulation development
    
  • Drug product manufacturing
    
  • Pharmaceutical process development
    
  • Senior MSAT Engineer
    
• 8+ years pharmaceutical industry experience
  
• Strong experience supporting sterile injectable products
  
• Must be authorized to work in the U.S.
  
• No C2C at this time

Benefits

• Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
  
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
  
• 401(k) and 401(k) matching
  
• PTO, Sick Time, and Paid Holidays
  
• Education Assistance
  
• Pet Insurance
  
• Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more)
  
• Financial Perks and Discounts