Director/Senior Director of Analytical Development - Analytical Development

Salary Range: 225000 to 275000 (Currency: USD) (Pay period: per-year-salary)

THE COMPANY

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.