Associate Director-Small Molecule, Analytical Development

About the Role

We're looking for an Associate Director, Analytical Development, Small Molecule on the Analytical Development team to help us expand what's possible for patients with serious diseases. Reporting to the Director, Analytical Development, you'll be responsible for leading and overseeing analytical development activities for small molecule drug substance and drug product programs across multiple dosage forms, including but not limited to oral solid, oral liquid, inhalation, and other specialized formulations. This role will provide strategic and technical leadership for analytical method development, qualification, validation, troubleshooting, and transfer activities to support product development from early-stage research through commercialization.

What You'll Do

• Lead analytical development activities for small molecule drug substance and drug product programs across multiple dosage forms, including oral solid, oral liquid, inhalation, and other emerging technologies.
• Develop and implement analytical strategies to support product development from preclinical and clinical stages through commercialization.
• Provide technical leadership for analytical method development, optimization, qualification, validation, verification, and lifecycle management in accordance with ICH, FDA, EMA, and other global regulatory expectations.
• Manage external analytical laboratories, CROs, CDMOs, and testing partners to ensure timely execution of analytical development activities, method transfers, validation studies, and stability testing.
• Review and approve analytical protocols, reports, method validation documents, specifications, development reports, and technology transfer packages.
• Provide analytical expertise and cross-functional support for nitrosamine and mutagenic impurity assessments, including strategy development, analytical testing, and regulatory support.
• Serve as the analytical subject matter expert for characterization of drug substances, intermediates, excipients, and drug products, including impurity profiling, degradation pathways, extractables and leachables assessments, and stability-indicating methodologies.
• Support formulation and process development activities through analytical troubleshooting, root cause investigations, and data-driven recommendations.
• Lead analytical method transfer activities between development, manufacturing, and external testing laboratories to ensure successful execution and regulatory compliance.
• Establish scientifically justified specifications and acceptance criteria for raw materials, drug substances, intermediates, and finished products throughout the product lifecycle.
• Author, review, and provide analytical content for regulatory submissions, including INDs, IMPDs, NDAs, MAAs, and other global filings.
• Support responses to regulatory agency questions and inspections.
• Collaborate closely with Pharmaceutical Development, Quality Assurance, Regulatory Affairs, Supply Chain, Manufacturing, and Project Management teams to achieve program objectives and development timelines.
• Ensure analytical activities are conducted in compliance with cGxP, ICH guidelines, USP/EP/JP requirements, and applicable regulatory standards.
• Evaluate emerging analytical technologies and industry best practices to drive continuous improvement, operational efficiency, and scientific innovation.
• Manage multiple analytical development programs simultaneously, identify technical and timeline risks, and develop effective mitigation strategies.
• Interpret complex analytical data, provide scientific leadership for problem-solving efforts, and contribute to overall CMC strategy and product development decisions.

Who You Are

You have a Bachelor's degree along with 10 years of experience in specifically analytical development with at least 5 years roles involving oversight of external testing laboratories. You are or you also have:

• Bachelor's degree in Chemistry, Biochemistry, or related discipline with 8+ years of experience in the pharmaceutical industry, specifically analytical development with at least 5 years roles involving oversight of external testing laboratories.
• Hands-on expertise in analytical lab testing for inhalation dosage forms and other small molecule dosage forms.
• Experience with inhalation and combination products is preferred.
• Strong knowledge and experience in nitrosamine risk assessment, including identification, evaluation, and control of nitrosamine impurities.
• Experience with mutagenic impurity assessment, including evaluation of potential genotoxic impurities and application of relevant regulatory guidance.
• Proficient in regulatory requirements, including cGxP, CMC, ICH, and compendial standards (USP/EP/JP).
• Excellent analytical and problem-solving skills, particularly in the context of technical troubleshooting and investigation management.
• Effective communication skills, both verbal and written, including experience drafting regulatory responses and QC sections of submissions.
• Strong organizational and project management skills, with a focus on timeliness, quality, and compliance.
• 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.