Description

You will be responsible for developing pharmaceutical formulations for early-stage clinical trials and preclinical studies, focusing on formulation strategies tailored to early development phases. You will collaborate with research scientists and external partners to address technical challenges and advance promising compounds toward clinical readiness. This role is critical in selecting developable drug candidates, reducing risk, and accelerating new chemical entities into the pipeline.

Requirements

• Advanced degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Materials Science, or related field
• Minimum of 10 years’ experience in progressively responsible roles in formulation and manufacturing process development
• Experience in leadership role desired
• Demonstrated success in formulations and dosage form development
• Experience authoring technical reports and CMC sections for regulatory filings
• Comprehensive understanding of physicochemical characterization of new drug candidates
• Extensive knowledge of cGMPs
• Skilled at managing Contract Service Providers (CSPs)
• Demonstrated verbal and written communication skills
• Adept at effectively aligning resources across multiple functional areas
• Flexibility to travel domestically and internationally

Responsibilities

• Design and develop pharmaceutical formulations to support early stage clinical trials
• Evaluate and validate new drug product Contract Service Providers (CSPs)
• Oversee operations at existing suppliers
• Initiate and manage supplier contract agreements
• Coordinate and supervise the development of clinical formulations and finished dosage forms at CSPs
• Serve as person-in-the-plant at CSP sites
• Plan project-related scientific and technical activities
• Plan conduct of preclinical and toxicological studies with Translational Sciences teams
• Develop phase appropriate formulations for new drug candidates in FIH, Phase 1 and POC studies
• Conduct physicochemical characterizations of new drug candidates
• Author and review technical reports and documents for regulatory submissions
• Review MBRs, BPRs, development reports and relevant documents prepared by CSPs
• Liaise with CMC team, late-stage formulation team, and formulation development management
• Adhere to cGMP work practices and work closely with Quality Assurance
• Collaborate with regulatory teams in preparation of health authority submissions
• Other responsibilities as assigned