Senior Parenteral Formulation Scientist

Sharp Services, LLC; Lee, Northern (MA, KY); Hybrid; USD 87,000 - 120,000; Full time

Job summary

Sharp Services, LLC in Lee, MA is seeking a Senior Formulation Scientist to design, develop, optimize and troubleshoot manufacturing processes for parenteral drug products. This hands-on role leads formulation development, process transfer, scale-up and manufacturing efforts.

You will work from R&D to production, identify critical quality attributes, manage documentation (batch records, SOPs), and ensure compliance with cGMP and FDA standards.

Qualifications

• Minimum of three years of experience in pharmaceutical research and manufacturing.
• Bachelor's degree or higher in Chemical Engineering, Chemistry, Biology or Pharmaceutical Science.
• Experience in sterile manufacturing and lyophilization is preferred.

Responsibilities

• Analyze excipients for compatibility with active drug molecules.
• Develop and optimize formulations with various excipients or solvents.
• Lead tech transfer and scale‑up from R&D to manufacturing.
• Create and review master batch records, SOPs, and related docs.
• Ensure compliance with cGMP and FDA standards.
• Provide training and supervise team members.
• Oversee validation activities.
• Carry out safety and quality initiatives.

Skills

Sterile manufacturing

Lyophilization

Data analysis

Microsoft Office

Technical writing

Education

Bachelor's degree in Chemical Engineering, Chemistry, Biology or Pharmaceutical Science

Job description

Sharp Services, LLC in Lee, MA is seeking a Senior Formulation Scientist to design, develop, optimize and troubleshoot manufacturing processes for parenteral drug products. This hands-on role leads formulation development, process transfer, scale-up and manufacturing efforts.

You will work from R&D to production, identify critical quality attributes, manage documentation (batch records, SOPs), and ensure compliance with cGMP and FDA standards.