Senior Formulation Scientist - Parenteral Drug Development

SHARP STERILE MANUFACTURING LLC; Lee (MA); On-site; USD 87,000 - 120,000; Full time

Job summary

SHARP STERILE MANUFACTURING LLC seeks a Senior Formulation Scientist in Lee, MA to design, develop, optimize and troubleshoot parenteral manufacturing processes. The role leads formulation development, scale-up and tech transfer from R&D to production, ensuring safety, quality and operational performance.

Requirements include a bachelor’s degree in a relevant field and 3+ years in pharmaceutical R&D/manufacturing, with sterile manufacturing and lyophilization experience highly valued.

Qualifications

• Three years of experience in pharmaceutical research and manufacturing.
• Bachelor’s degree or above in Chemical Engineering, Chemistry, Biology or Pharmaceutical Science.
• Experience in sterile manufacturing preferred.
• Lyophilization and terminal sterilization experience a plus.
• Knowledge of parenteral drug product manufacturing.
• Strong data analysis, statistics and applied mathematics skills.
• Proficient with Microsoft Office and technical writing.

Responsibilities

• Analyze excipients to determine compatibility with active drug molecules for stable products.
• Evaluate changes in composition or stability due to heat, light, or catalysts.
• Develop formulations with different excipients or solvents at laboratory scale.
• Propose and develop lyophilization or other complex formulation processes; scale-up.
• Lead process transfer from R&D to manufacturing and support tech transfer.
• Create master batch records, SOPs and related quality documents ensuring cGMP compliance.
• Participate in risk analysis and process optimization for safety and quality.
• Supervise, mentor and develop team members across departments.

Skills

Sterile manufacturing

Lyophilization

Terminal sterilization

Parenteral manufacturing

Data analysis

Statistics

Mathematics

Technical writing

MS Office

Education

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

Job description

SHARP STERILE MANUFACTURING LLC seeks a Senior Formulation Scientist in Lee, MA to design, develop, optimize and troubleshoot parenteral manufacturing processes. The role leads formulation development, scale-up and tech transfer from R&D to production, ensuring safety, quality and operational performance.

Requirements include a bachelor’s degree in a relevant field and 3+ years in pharmaceutical R&D/manufacturing, with sterile manufacturing and lyophilization experience highly valued.