Job DescriptionPosition SummaryWe are seeking an experienced analytical chemistry professional to provide strategic and technical support for small molecule programs progressing through late-stage development toward regulatory submission.
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.
QualificationsQualifications- 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.
Additional InformationDue to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate's experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate's qualifications, consistent with applicable law.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.
