• Support the technical operations department as a subject matter expert, technical transfer liaison and technical writer on parenteral drug product manufacturing projects.
  
• Serve as Manufacturing representative on client project teams.
  
• Stays current with bodies of knowledge, identifying best practices, regulatory requirements, industry standards and trends.
  
• Share knowledge gained with Singota employees.
  
• Identify process improvements, support planning and implementation, and track metrics.
  
• Author, edit, review, and execute procedures and protocols.
  
• Author Batch Records and Specification sheets for Formulation, Filling, Inspection and Finishing.
  
• Collaborate in writing and responding to deviations, investigations, and corrective actions.
  
• Maintains knowledge of and performs functions in compliance with laws and regulations including but not limited to Company’s policies and standard operating procedures, FDA and similar regulatory authorities.
  
• Positive Attitude and willingness to work as part of a diverse team to achieve overall goals of the company.
  
• Comply with quality and safety management systems including requirements for documentation, training, system use, SOPs, processes, and procedures. Ensure procedures are followed and changed if no longer applicable.
  
• General support required of a company where everyone is expected to perform multiple tasks both inside and outside their department to meet the needs of the business.
  
• Operational knowledge of Cytiva/Vanrx SA25 or other robotic filling isolator is a plus.
  

• Able to support the client team as a subject matter, in organizing and leading meetings, and driving projects to meet operational deliverables.
  
• Proficient with electronic systems, including but not limited to enterprise resource planning (ERP), and Microsoft Office applications, particularly Word, Excel, PowerPoint and Project.
  
• Trustworthiness and personal integrity – able to maintain a high degree of confidentiality
  
• Strong verbal, listening and written communication skills.
  
• Good time management and organizational skills.
  
• Positive attitude and good judgment.
  
• Customer focused both to internal staff and external clients.
  
• Proficient math and chemistry skills required, including knowledge of manufacturing methods.
  
  

Requirements

• Bachelor’s degree in a scientific discipline and 5+ years’ experience in pharma industry, formulation and aseptic manufacturing experience preferred
  
• Or
  
• Associates degree in a scientific discipline and 8+ years’ experience in the pharma industry, formulation and aseptic manufacturing experience required.
  
  

Benefits

• 401(k)
  
• 401(k) matching
  
• Dental insurance
  
• Health insurance
  
• Health savings account
  
• Life insurance
  
• Paid time off
  
• Retirement plan
  
• Tuition reimbursement
  
• Vision insurance