In this position, you will lead the design, planning, and implementation of pre-formulation and formulation development strategies with minimal supervision. Your main objective will be to evaluate the viability of intricate innovative ideas and produce data to support Intellectual Property (IP). Your duties will encompass coordinating process development initiatives, supervising pilot batches in compliance with cGMPs, establishing project objectives and schedules, and conducting in-depth data analysis using statistical methodologies.

Responsibilities:

• Planning and overseeing cGMP pilot batches, including protocol, batch record, and report reviews.
• Overseeing early development with external labs, CROs, and CDMOs.
• Writing and reviewing regulatory submissions and scientific information packages.
• Performing pre-formulation and formulation development.
• Analyzing physical and chemical characterization data and addressing formulation issues.
• Preparing technical reports and regulatory submissions for internal and external use.

Qualifications:

• Bachelor's degree in Pharmaceutical Science or a related scientific field with at least 15 years of experience in pharmaceutical formulation and product development
• Master's degree in Pharmaceutical Science or a related scientific field with a minimum of 12 years of experience in pharmaceutical formulation and product development,
• PhD in Pharmaceutical Science or a related scientific field with at least 7 years of experience in pharmaceutical formulation and product development. 
  

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