Senior Director, Analytical Chemistry

Responsibilities:
- Lead analytical development and material characterization for existing and new compounds appropriate to the phase of development.
- Establish phase-appropriate analytical method strategy for small molecule DS/DP, including solid-state characterization and impurity profiling.
- Provide expertise in analytical testing including DSC, IR, particle size, GC, mass spectrometry, XRD, and common pharmaceutical methodologies.
- Oversee external CDMO partners for development, optimization, qualification, validation, and transfer of analytical methods; troubleshoot issues/non-conformances, determine root cause, and optimize testing.
- Support formulation development with material testing, impurity/degradation identification; support pre-clinical test article characterization.
- Investigate and resolve complex analytical deviations, OOS results, and stability trends.
- Author/review analytical CMC sections and relevant bioanalytical components for IND through NDA and ROW regulatory submissions.

Qualifications:
- PhD/Master’s/Bachelor’s in physical science field (ideally analytical chemistry or related).
- ≥12 years analytical chemistry experience in small molecule testing (biologics/large molecule experience not counted).
- Experience with early development/IND-enabling activities.
- Strong API and impurity testing experience (drug product only not sufficient).
- Preferred: supervised outsourced plasma concentration analysis using LC-MS/MS in GLP and per FDA/EMA bioanalytical method validation guidelines.
- Expertise in LC, GC, NMR, MS, XRPD and related methodologies.
- Knowledge of FDA/EMA/ICH guidelines for drug substance manufacturing and quality assurance.
- Excellent written/verbal communication; strong interpersonal skills; attention to detail; strong MS Office skills; ability to work independently or as part of a team.

Benefits:
- Annual performance incentive bonus; new hire equity package; medical/dental/vision; 401(k) match; PTO; paid holidays.