Senior Analytical Chemistry Consultant (Small Molecule)

Position Summary

The ideal candidate will bring deep expertise in analytical method development and validation, CMC documentation, and management of analytical activities at contract development and manufacturing organizations (CDMOs) for both Drug Substance (DS) and Drug Product (DP) with significant experience in late-stage development (Phase 3 to Commercialization).

You will serve as the primary technical liaison for our CDMO partners, ensuring robust method validation, seamless technology transfer, and rigorous quality control. Additionally, you will play a hands-on role in authoring CMC sections for global regulatory filings (IND/NDA/IMPD).

Key Responsibilities - Expectations

• Provide technical oversight of external analytical resources at CDMOs, acting as the primary point of contact for troubleshooting and deviation resolution.
• Manage the transfer, optimization, and validation of analytical methods for both DS and DP, ensuring compliance with ICH guidelines and GMP requirements.
• Review and approve CDMO protocols, reports, and raw data for method validation, stability studies, and release testing.

• Assess and mitigate technical risks related to analytical control strategies, degradation pathways, and impurity profiling (including genotoxic impurities).
• Review and interpret analytical data, ensuring data integrity, traceability, and regulatory compliance.
• Participate in risk assessments related to analytical control and product quality.

• Lead the design and execution of late-stage method validation strategies (Phase 3/PPQ readiness) to ensure methods are commercially viable and robust.
• Oversee forced degradation studies and stability-indicating method development for complex small molecule formulations.
• Establish specification justifications for DS and DP based on clinical batch data, stability trends, and regulatory expectations.

• Draft, review, and edit analytical CMC sections (Module 3) for regulatory submissions, including IND amendments, NDA/MAA filings, and briefing books.
• Author and review responses to Information Requests (IRs) from health authorities (FDA, EMA) regarding analytical topics.
• Ensure analytical control strategies align with Quality by Design (QbD) principles and current regulatory expectations.

Qualifications

• Ph.D. in Analytical Chemistry or related field with 10 years of industry experience (or M.S. with 15 years).
• Extensive experience with Small Molecule therapeutics in both Drug Substance and Drug Product is mandatory
• Proven track record in late-stage development, specifically Phase 3 to Commercial launch.

• Expert knowledge of ICH guidelines (Q1, Q2, Q3, Q6, Q7, Q14) and cGMP requirements.
• Demonstrated experience managing external partners (CROs/CMOs) and holding them accountable to timelines and quality standards.
• Experience overseeing analytical work at CDMOs/CROs, including protocol and report review, data trending, and deviation management.
• Solid understanding of GMP principles, data integrity standards, and regulatory expectations for analytical control strategies.

• Hands-on experience authoring and reviewing Module 3 (Quality) sections for NDAs/MAAs.

• Passionate about enabling and leading a collaborative, transparent culture and integrating quickly into cross-functional teams (Process Chem, Formulation, QA/RA).
• Strong technical writing skills and the ability to explain complex data to non-analytical stakeholders.