Scientist - Biotech jobs in the United States

• Develop and optimize formulations and process flows for sterile injectable and liquid products.
  
• Coordinate with cross-functional departments to plan, schedule, and drive required formulation, development, and manufacturing activities to achieve successful client product/process development execution. 
  
• Effectively evaluate customer needs to best establish and develop unique formulation and compounding processes. Ensure strong understanding of properties of drug substances and excipients and finalize formulation compositions.
  
• Develop, design, and conduct pre-formulation and formulation studies/trials and analytical testing. Analyze and evaluate the impact of various formulation components on product stability, compatibility, quality, and efficiency.
  
• Adapt or modify experimental methods to achieve technical objectives.
  
• Responsible for participating in manufacturing fills.
  
• Develop and optimize lyophilization cycles for new and existing products.
  
• Provide technical guidance and expertise, troubleshooting and resolving any potential risks or issues, utilizing experimental and analytical methods.
  
• Responsible for all formulation related documentation and reports. Prepare and review technical documents, including protocols, procedures, stability reports, batch records, regulatory submissions, etc.
  
• Participate in cross-functional project teams and contribute to the overall success of product development initiatives.
  
• Identify opportunities for innovation and continuous improvement in formulation and process development.
  
• Effectively ensure compliance with regulatory requirements and company standards. Maintain strong understanding of current laws and regulations applicable to the pharmaceutical industry.
  
• Additional responsibilities as required.
  

Requirements

• Bachelors (minimum) or advanced degree in pharmaceutical sciences, chemical engineering, chemistry, or related. 
  
• 5 years of experience developing formulations within pharmaceutical manufacturing industry, specifically within sterile injectables.
  
• Proven success in developing and process flows and formulations independently.
  
• Advanced understanding of pharmaceutical manufacturing processes and required industry regulations.
  
• Strong knowledge of lyophilization principles, techniques, and equipment.
  
• Strong knowledge of manufacturing and formulation equipment.
  
• Experienced with various analytical techniques.
  
• Proven ability to effectively problem solve, analyze, and interpret formulation requirements and processes.
  
• Strong communication skills, both written and verbal, with the ability to prepare and present technical information clearly.
  
• Prior experience managing projects from conception to completion with responsibility and accountability of project outcome and deliverables is a plus.
  

Benefits