Director/Senior Director, Analytical Development

Analytical Development Strategy

• Develop and execute the analytical development strategy supporting the company's pipeline from preclinical development through clinical development.

• Define analytical requirements for starting materials, drug substance and drug product, including release, stability, characterization, and in-process testing.

• Establish appropriate analytical control strategies aligned with product and process understanding and the stage of development.

• Provide analytical development leadership for CMC activities supporting regulatory submissions, including the IND and subsequent clinical-stage filings.

• Identify analytical risks and develop appropriate mitigation strategies.

Method Development, Qualification & Validation

• Lead development, optimization, qualification, and validation of analytical methods for complex pharmaceutical molecules.

• Develop methods for attributes including identity, purity, impurities/degradants, potency, concentration, physical properties, and product-related variants.

• Establish scientifically sound analytical procedures and acceptance criteria appropriate to the stage of development.

• Design and oversee method validation studies in accordance with applicable ICH and regulatory expectations.

• Develop analytical method lifecycle strategies, including transfer, qualification, validation, and ongoing monitoring.

• Evaluate analytical methods for robustness, specificity, accuracy, precision, linearity, range, detection/quantitation limits, and other applicable performance characteristics.

Peptide / PEG Analytical Development

• Lead analytical characterization of peptide- and/or PEG-containing molecules, as applicable to the company's pipeline.

• Develop strategies for characterization and quantitation of molecular heterogeneity, impurities, degradation products, aggregates, and other product-related species.

• Experience with techniques such as HPLC/UPLC, LC-MS, SEC, ion exchange, peptide mapping, spectroscopy, and related chromatographic and mass spectrometric approaches is highly desirable.

• Establish fit-for-purpose analytical approaches for complex molecules where conventional methods may require significant development or customization.

• Experience with comparability testing for the 505(b)2 regulatory pathway is a plus.

GMP & Clinical Readiness

• Ensure analytical methods and supporting documentation are appropriate for GMP manufacturing and clinical supply.

• Partner with Quality, CMC and Regulatory colleagues to establish analytical procedures, specifications, sampling plans, and stability programs.

• Support analytical aspects of drug substance and drug product release and stability testing.

• Provide analytical oversight of external testing laboratories, CROs, and CDMOs.

• Review analytical data, reports, protocols, method validation packages, certificates of analysis, and other technical documentation.

• Support investigations, out-of-specification/out-of-trend investigations, deviations, and analytical troubleshooting as needed.

External Partner Management

• Establish and manage relationships with analytical CROs, contract laboratories, and CDMOs.

• Define analytical scopes of work, technical requirements, timelines, and deliverables.

• Provide scientific oversight and critically evaluate externally generated data.

• Ensure external analytical activities remain aligned with development timelines and regulatory requirements.

Leadership & Cross-Functional Collaboration

• Build and lead the company's analytical development capabilities as the organization grows.

• Collaborate closely with CMC, Process Development, Manufacturing, Quality, Regulatory, Clinical, and Program Management functions.

• Translate analytical data into clear scientific conclusions and development recommendations.

• Represent Analytical Development in internal program reviews and external interactions with partners and regulatory agencies.

• Contribute to the development of a high-performing, collaborative, and scientifically rigorous company culture.
• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Chemistry, or a related scientific discipline, or equivalent industry experience.

• 10+ years of relevant pharmaceutical/biotechnology industry experience, with increasing responsibility in analytical development.

• Demonstrated experience developing and implementing analytical methods for pharmaceutical products.

• Strong experience with analytical method development, qualification, and validation.

• Experience supporting CMC activities for clinical-stage programs and/or regulatory submissions.

• Strong understanding of analytical characterization, specifications, stability, and analytical control strategies.

• Experience working with GMP laboratories and external analytical testing organizations.

• Demonstrated ability to independently interpret complex analytical data and make sound scientific decisions.

• Excellent written and verbal communication skills.

• Ability to work effectively in a small, entrepreneurial, cross-functional environment.

Preferred

• Experience with peptides, PEGylated molecules, bioconjugates, or other complex therapeutic modalities.

• Experience with analytical characterization of chemically heterogeneous or structurally complex molecules.

• Hands-on expertise with HPLC/UPLC, LC-MS, SEC, ion-exchange chromatography, peptide mapping, and related analytical technologies.

• Experience developing analytical methods for both drug substance and drug product.

• Experience authoring or reviewing analytical sections of INDs, IMPDs, or other regulatory submissions.

• Experience transferring methods to GMP laboratories and/or CDMOs.

• Experience establishing an analytical function within a small or growing biotechnology company.

• Prior experience managing scientists or analytical development personnel.

• Regulatory-minded — understands what makes analytical methods scientifically defensible and inspection-ready.

Director - $225,000 - $250,000
Senior Director - $250,000 - $275,000

The expected salary range for this role is $225,000 to $275,000 per year. Final compensation will reflect the candidate's qualifications, experience, and geographic location. Employees are also eligible for a performance bonus, equity participation, and comprehensive health benefits.