Senior Scientist, Analytical Development - Small Molecule

What You'll Do

In this role, you'll have the opportunity to lead the development and optimization of analytical methods for starting materials, intermediates, drug substances, and drug products. You'll also:

• Utilize a wide range of analytical techniques, including HPLC, GC, LC-MS, NMR, UV, and FTIR, to ensure method suitability for intended applications.
• Design and lead method validation activities to ensure compliance with ICH, FDA, EMA, and other applicable regulatory guidelines.
• Oversee method development and transfer activities to manufacturing or quality laboratories, ensuring clear documentation and effective technology transfer.
• Prepare, review, and approve technical documents, including standard operating procedures (SOPs), analytical methods, protocols, reports, and product specifications.
• Author and review analytical sections of regulatory submissions (IND, IMPD, NDA/MAA) and support regulatory interactions as an analytical subject matter expert.
• Collaborate with process chemistry, development teams, quality assurance, and regulatory affairs to ensure analytical needs are met across the product lifecycle.
• Lead or contribute to cross-functional project teams, manage analytical development timelines, and communicate progress to stakeholders.
• Serve as the Analytical Lead for CMC programs, overseeing analytical deliverables, including method development, validation, and GMP testing for both internal teams and external partners.
• Manage and oversee external service providers supporting analytical development activities, ensuring timely deliverables and continuous process improvements.
• Provide technical troubleshooting, data interpretation, and review of analytical data, including method validation documents, Certificates of Analysis (CoAs), and stability reports.
• Lead the design and development of phase-appropriate quality control strategies, specifications, and stability programs for drug substances and drug products.
• Contribute to CMC operations, including execution, process improvements, and development of operational capabilities.
• Collaborate with cross-functional teams across the organization to establish and enhance technical and business practices.
• Perform additional responsibilities as assigned to support evolving departmental needs.

Who You Are

You have a bachelor's degree in chemistry, Biochemistry, or related discipline with 6+ years of experience, or master's degree with 4+ years of experience. 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).
• Strong commitment to laboratory work with meticulous attention to detail.
• Advanced proficiency in Microsoft Office tools.
• 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.