Scientist, Analytical Development, Small Molecule

What You'll Do

In this role, you'll have the opportunity to take the responsibility for small molecule products analytical routine testing (inhalation combination products, tablet formulations, and oral solutions) from early-stage development through to Phase III and commercialization. You'll also:

• Ensure all testing is performed in compliance with GMP regulations and internal standard operating procedures (SOPs).
• Accurately recording and reporting test results, maintaining detailed and compliant documentation in accordance with GMP.
• Validate analytical methods using advanced techniques (e.g., HPLC, UPLC, GC, XRPD, Raman, PSD, FTIR, Dissolution and more) to support drug substance and drug product characterization.
• Work closely with formulation scientists, process development teams, and regulatory groups to support CMC activities, ensuring analytical methods meet the necessary regulatory standards.
• Lead pre-formulation and stability studies for small molecule drug products to assess their shelf life and ensure product quality during development and commercialization.
• Analyze complex data, identify potential issues in analytical methods or product quality, and propose scientifically sound solutions to overcome technical challenges.
• Prepare technical documents such as protocols, development reports, validation reports, and regulatory submissions, ensuring they are compliant with cGMP and regulatory requirements.
• Contribute to regulatory filings (IND, NDA), including providing the necessary analytical data and documentation required for submissions to global health authorities.
• Ensure all analytical activities comply with cGxP, ICH guidelines, and regulatory standards for the pharmaceutical industry, including USP/EP/JP requirements.
• Interpret complex data to solve challenging problems and provide scientific direction within the AR&D laboratory.

Who You Are

You have a Bachelor's degree along with five years of experience in Chemistry. You are or you also have:

• Hands-on expertise in analytical lab testing for inhalation dosage forms, solid oral and liquid dosage forms.
• Experience with inhalation and combination products is preferred.
• Proficient in regulatory requirements, including cGxP, CMC, ICH, and compendial standards (USP/EP/JP).
• Ability to conduct risk assessments and develop analytical methods for the detection and control of nitrosamine impurities, ensuring compliance with regulatory guidelines.
• Strong commitment to laboratory work with meticulous attention to detail.
• Advanced proficiency in Microsoft Office tools.
• Excited to contribute to a fast-paced, team-oriented environment focused on accelerating early-stage drug development.
• Must embody the core values of Collaboration, Accountability, Passion, Respect, and Integrity, and demonstrate the ability to work in a diverse, dynamic environment.
• Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

Where You'll Work

This role is based out of our Bridgewater, NJ office and requires full-time, in-person presence to support hands-on collaboration, access specialized equipment, and/or operational needs. Travel Requirements: Minimal travel expected.