This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Oversee the design, development, and implementation of analytical methods that are appropriate for each phase, adhering to ICH and Health Authority regulations.

• Conduct release and stability testing on starting materials, intermediates, and APIs for both development and GMP samples.

• Create and review technical documentation such as method qualification, validation, and transfer protocols, along with reports for analytical methods.

• Maintain and resolve issues with analytical instruments.

• Play a vital role in ensuring audit readiness and take part in quality audits with the FDA, other regulatory bodies, and clients as required.

• Ensure adherence to all applicable state and federal regulations, including but not limited to GMP, DEA, and FDA standards.

⛳️ Requirements

• Bachelor’s degree in Analytical Chemistry or a related field with over 5 years of relevant experience in analytical development (R&D and method qualification/validation) within the pharmaceutical sector.

• Master’s degree in Analytical Chemistry or a related field with a minimum of 3 years of relevant experience in analytical development (R&D and method qualification/validation) within the pharmaceutical sector.

• PhD in Analytical Chemistry or a related field with relevant experience in analytical development (R&D and method qualification/validation) within the pharmaceutical sector.

• Proficiency in common analytical techniques such as HPLC/UPLC, GC, NMR, UV, KF, FTIR, XRPD, LC-MS, GC-MS, and ICP-MS.

• At least 5 years of experience in method development and validation for small molecule Active Pharmaceutical Ingredients (APIs).

• Experience in the Process Development of APIs.

• Previous leadership experience is preferred.