We are seeking a highly skilled and motivated Director with a strong background with formulation Development within the biotechnology space. They will be responsible for managing the analytical aspect of portfolio projects with the responsibilities to serve as a formulation development and drug product subject matter expert.
Director, Formulation Development Key Responsibilities:
- Lead the development of drug product formulations and manufacturing processes for both new and existing chemical entities across pre-clinical and clinical programs, emphasizing formulation process design, technology selection, process development, data analysis, fundamental process understanding, and drug product characterization.
- Manage the design, planning, execution, and delivery of studies related to formulation and process development, as well as the provision of toxicology study/clinical supplies, process performance qualification, and technology transfer for oral and sterile liquid and/or lyophilized parenteral drug products, covering both small and large molecules.
- Implement a Quality by Design (QbD) approach to enhance drug formulation and manufacturing processes, ensuring consistent product quality.
- Facilitate the selection process for Contract Service Providers through diligent evaluation.
- Oversee outsourced drug product development and execution at Contract Development and Manufacturing Organizations (CDMOs), including the preparation of request for proposal documents, review of proposals, monitoring of project activities, provision of progress reports, and troubleshooting as needed, while maintaining an on-site presence at CDMOs to meet project objectives.
Director, Formulation Development Qualifications:
- Ph.D. in Chemistry or a related field.
- A minimum of 12 years' experience including pharmaceutical development experience.
- Solid scientific foundation and extensive experience in developing oral solid/liquid dosage forms (small molecule), including expertise in manufacturing processes, scale-up, technology transfer, and in-process control testing. Familiarity with biologic product formulation is advantageous.
- Skilled in comprehending intricate processes, pinpointing knowledge deficiencies, and devising streamlined solutions to challenges.
- Capability to evaluate third-party capacities and facilities to aid in selecting contract development and manufacturing organizations (CDMOs) is beneficial.
Compensation for this position is competitive + package (commensurate to experience and background).
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