ARD Director, Small Molecule Analytics

NJ Bio; Princeton (NJ); On-site; USD 182,000 - 200,000; Full time

Job summary

NJ Bio, Inc. in Princeton, NJ seeks an ARD Director to lead analytical development activities for small molecule linker payloads, APIs, intermediates, mAbs, proteins, ADCs, and other modalities.

You will develop and qualify analytical methods, shape analytical strategies with clients, and manage a team while ensuring compliance with FDA regulations and SOPs. Travel up to 5% may be required.

Qualifications

• Master’s degree in Chemistry, Pharmaceutical Sciences, or closely related field is required.
• 2+ years of senior-level analytical chemist experience in pharma/biotech.
• Experience with HPLC method development/validation (SEC, RP, IEX, HIC) for large molecules.
• Release/stability testing and method validation per FDA regulations.
• Knowledge of CMC regulatory, Process/Analytical Development, and GMP.

Responsibilities

• Lead analytical method development/qualification for small molecules, APIs, and ADCs in a cGMP environment.
• Manage and develop teams; provide periodic client presentations.
• Collaborate cross-functionally with internal departments and QA on analytical strategies.
• Ensure compliance with FDA regulations and company SOPs.
• Travel to conferences or partner facilities up to 5%.

Skills

HPLC method dev

Method validation

cGMP experience

Large molecule analytics

Education

Master's degree in Chemistry or Pharmaceutical Sciences

Job description

NJ Bio, Inc. in Princeton, NJ seeks an ARD Director to lead analytical development activities for small molecule linker payloads, APIs, intermediates, mAbs, proteins, ADCs, and other modalities.

You will develop and qualify analytical methods, shape analytical strategies with clients, and manage a team while ensuring compliance with FDA regulations and SOPs. Travel up to 5% may be required.