Senior Development Chemist

I am currently partnered with a pharmaceutical organization seeking a Senior Analytical Chemist / Dissolution Method Development Chemist (Contract) to support a critical GMP initiative focused on bringing dissolution method development in-house.

This role is ideal for a senior-level analytical chemist with strong dissolution method development experience, hands-on UPLC expertise, and background supporting oral solid dose or pellet based formulations in regulated pharmaceutical environments.

Responsibilities:

• Lead dissolution method development and validation for pellet-based oral solid dosage forms under cGMP conditions
• Execute dissolution studies using USP Apparatus I (basket) systems, including Sotax platforms
• Develop and optimize dissolution methods
• Perform API quantitation via UPLC on dissolution media collected at defined timepoints
• Draft internal Test Method documents, validation protocols, and summary reports
• Collaborate with senior lab and Quality leadership to support in-house capability build and inspection readiness

Required Qualifications:

• 8 years of hands-on analytical chemistry experience, with significant ownership of dissolution method development and validation in GMP-regulated environments.
• Bachelor’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related discipline
• Strong hands-on experience with dissolution method development in a regulated environment
• Proven experience developing and validating methods for oral solid dose products (tablets, capsules, pellets, multiparticulates)
• Direct experience using UPLC or HPLC systems for analytical method development (Waters, Agilent, or similar)
• Experience working in GMP-regulated laboratories
• Experience authoring method development, validation, and technical transfer documentation

This is an excellent opportunity for a senior analytical professional who enjoys hands-on technical ownership and working on complex dissolution challenges.