About this role
Responsibilities
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.
Qualifications
- 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.