Summary

Our client is seeking an experienced Formulation Chemist to support the development of lyophilized injectable vials and oral capsule formulations on a project-based (Statement of Work / Per Diem) basis. This role is ideal for a pharmaceutical formulation expert with hands-on experience developing injectable and oral solid-dose products who can independently lead formulation activities from concept through regulatory readiness.

The successful candidate will have expertise in formulation development, excipient selection, lyophilization, stability studies, GMP documentation, and technical writing while collaborating with Quality, Regulatory, Manufacturing, and Analytical teams to support product commercialization.

Duties & Responsibilities

Formulation Development

• Develop formulations for lyophilized injectable vials and oral capsule products.
• Design and execute formulation development studies, including excipient selection, buffer optimization, and compatibility assessments.
• Troubleshoot formulation challenges related to solubility, stability, aggregation, dissolution, and product performance.
• Support scale-up activities from laboratory development through manufacturing.

Lyophilization & Injectable Products

• Develop and optimize lyophilization cycles, including freezing, primary drying, and secondary drying.
• Investigate and resolve reconstitution and product stability issues.
• Support sterile fill-finish activities, ensuring compatibility with filtration systems and filling equipment.

Oral Solid Dose Development

• Develop oral capsule formulations, including excipient compatibility and fill-weight uniformity.
• Evaluate formulation performance and identify opportunities to improve bioavailability where appropriate.
• Generate technical data packages supporting manufacturing partners.

Stability, Documentation & Regulatory Support

• Design and execute accelerated and long-term stability studies in accordance with ICH guidelines.
• Prepare formulation development reports, technical protocols, batch records, and supporting GMP documentation.
• Collaborate with Quality and Regulatory teams to ensure formulation data supports regulatory compliance, including 503A/503B requirements.
• Support manufacturing and analytical teams by providing formulation expertise throughout the product lifecycle.

Qualifications & Requirements

Required Experience

• Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline (PhD preferred).
• Minimum 3 years of pharmaceutical formulation experience developing both injectable (lyophilized) and oral solid-dose products.
• Hands-on experience with lyophilization cycle development and freeze-drying equipment.
• Experience developing oral capsule formulations, including excipient selection and fill-weight optimization.
• Strong understanding of formulation challenges, including solubility, stability, aggregation, and excipient compatibility.

Technical Skills

• Experience designing and executing formulation development studies.
• Knowledge of GMP documentation, batch records, technical protocols, and formulation reports.
• Familiarity with ICH stability guidelines and stability protocol development.
• Understanding of USP <795>, USP <797>, and/or 503A/503B regulatory requirements preferred.
• Experience supporting sterile fill-finish operations and aseptic processing is highly desirable.

Professional Skills

• Strong technical writing and documentation skills.
• Excellent analytical, problem-solving, and troubleshooting abilities.
• Ability to work independently while collaborating with cross-functional teams.
• Strong organizational skills with the ability to manage multiple project priorities.