Director/Senior Director, Analytical Development

THE COMPANY

Prolynx is a preclinical biotechnology company with a vision to become the industry leader in ultra-long-acting medicines that improve outcomes for patients with obesity, cardiometabolic, and other diseases. The company is developing a next-generation portfolio of incretin and non-incretin therapeutics designed for once-monthly and once-quarterly dosing. Its proprietary, first-in-category platform uses a hydrogel-based microsphere technology with independently tunable release-linker chemistry to enable highly predictable pharmacokinetics and sustained drug exposure. Prolynx is backed by leading investors including 5AM Ventures, OrbiMed, and Monograph Capital and is based in Emeryville, CA.   Join a multidisciplinary team of talented scientists developing innovative and differentiated medicines - where we pursue purposeful science and let data and patient needs drive decisions.  Prolynx provides an environment where you work, learn, and grow alongside experienced drug developers, inventive scientists, and business professionals.  Bring your passion, creativity, and energy to our mission. At Prolynx, contributions are valued regardless of title, people are trusted to own their area of expertise, and teammates readily step in to help one another. We share what we know and succeed together. If that sounds like the place for you, we’d like to meet you.

POSITION SUMMARY

We are seeking a highly motivated and experienced Director of Analytical Development to lead the development, qualification, validation, and implementation of analytical methods supporting our preclinical and clinical-stage programs.   The Director will be responsible for establishing and executing the analytical development strategy across starting materials, drug substance and drug product. This individual will play a critical role in preparing the company for clinical development and establishing an analytical control strategy that can evolve with the programs through later-stage development.   The ideal candidate is a scientifically rigorous, hands-on analytical development leader who has experience taking analytical methods from early development through method qualification/validation and GMP implementation. Experience with peptides, PEGylated molecules, other complex biologics/bioconjugates as well as particulates is highly desirable. Demonstrated ability to grow an Analytical Development organization as well as manage CRO/CDMOs is a plus.   This is an important leadership role in a small, fast-moving organization. The successful candidate will be comfortable operating strategically while also diving into experimental details, troubleshooting challenging analytical problems, and working closely with internal teams and external CRO/CDMO partners.

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.

We believe in building an inclusive and balanced team, and we know that strong candidates may not meet every qualification listed. If this opportunity interests you, we encourage you to apply. 

Prolynx is an equal opportunity employer. We do not discriminate based on race, color, religion, national origin, age, sex, sexual orientation, gender identity, marital status, ancestry, physical or mental disability, veteran status, or any other status protected by applicable law. 

Prolynx does not accept unsolicited resumes from recruitment agencies or external recruiters. No fees will be paid for unsolicited submissions.