Director/Senior Director, Analytical Development

5AM Ventures•Emeryville, CA

3d•$225,000 - $275,000

About The Position

Prolynx is a preclinical biotechnology company developing ultra-long-acting medicines for obesity, cardiometabolic, and other diseases. Its hydrogel-based microsphere platform is designed to support once-monthly and once-quarterly dosing. The company is based in Emeryville, California, and offers a collaborative environment in which team members take ownership, share knowledge, and work together on purposeful, data-driven science. The Director/Senior Director of Analytical Development will lead the development, qualification, validation, and implementation of analytical methods for preclinical and clinical-stage programs. This role establishes and executes analytical strategy across starting materials, drug substance, and drug product; supports clinical readiness and CMC regulatory submissions; and develops analytical control strategies that can mature as programs advance. The position combines strategic leadership with hands-on scientific work, including troubleshooting analytical challenges and collaborating with internal teams and external CRO/CDMO partners. The successful candidate will bring substantial pharmaceutical or biotechnology analytical development experience, including methods taken from early development through qualification or validation and GMP implementation. Experience with peptides, PEGylated molecules, complex biologics or bioconjugates, and particulates is desirable. The role may also build the company's Analytical Development capabilities as the organization grows.

Requirements

Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Chemistry, or a related scientific discipline, or equivalent industry experience.
At least 10 years of relevant pharmaceutical or biotechnology industry experience, with increasing responsibility in analytical development.
Demonstrated experience developing and implementing analytical methods for pharmaceutical products.
Strong experience in 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.
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.

Nice To Haves

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 approach, including understanding how to make analytical methods scientifically defensible and inspection-ready.
Experience with comparability testing for the 505(b)(2) regulatory pathway.

Responsibilities

Develop and execute analytical development strategy for the pipeline from preclinical through clinical development.
Define analytical requirements for starting materials, drug substance, and drug product, including release, stability, characterization, and in-process testing.
Establish stage-appropriate analytical control strategies based on product and process understanding.
Lead analytical development contributions to CMC activities and regulatory submissions, including INDs and later clinical-stage filings.
Identify analytical risks and develop mitigation strategies.
Lead development, optimization, qualification, and validation of analytical methods for complex pharmaceutical molecules.
Develop methods to assess identity, purity, impurities and degradants, potency, concentration, physical properties, and product-related variants.
Establish scientifically sound analytical procedures and acceptance criteria appropriate to each development stage.
Design and oversee method validation studies consistent with applicable ICH and regulatory expectations.
Develop method lifecycle strategies covering transfer, qualification, validation, and ongoing monitoring.
Assess method robustness, specificity, accuracy, precision, linearity, range, detection and quantitation limits, and other relevant performance characteristics.
Lead analytical characterization of peptide- and/or PEG-containing molecules, as applicable to the pipeline.
Develop approaches to characterize and quantify molecular heterogeneity, impurities, degradation products, aggregates, and other product-related species.
Establish fit-for-purpose analytical approaches for complex molecules, including cases requiring substantial method development or customization.
Ensure analytical methods and documentation are appropriate for GMP manufacturing and clinical supply.
Work with Quality, CMC, and Regulatory colleagues to establish procedures, specifications, sampling plans, and stability programs.
Support drug substance and drug product release and stability testing.
Provide analytical oversight of external testing laboratories, CROs, and CDMOs.
Review analytical data, reports, protocols, validation packages, certificates of analysis, and other technical documentation.
Support investigations, including out-of-specification and out-of-trend investigations, deviations, and analytical troubleshooting.
Establish and manage relationships with analytical CROs, contract laboratories, and CDMOs.
Define external analytical scopes of work, technical requirements, timelines, and deliverables.
Provide scientific oversight of external work and critically evaluate externally generated data.
Keep external analytical activities aligned with development timelines and regulatory requirements.
Build and lead the company's Analytical Development capabilities as the organization grows.
Collaborate 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 a high-performing, collaborative, and scientifically rigorous company culture.