# Director/Senior Director, Analytical Development at 5amventures > Onsite · United States · Director+ · Other · open. Source: https://alderhq.app/jobs/lever%3A5amventures%3A36bdb00b-62ea-4dcf-b9a4-11dbb95d677d (read 2026-11-13). ## Facts (observed) - Company: [5amventures](https://alderhq.app/companies/5amventures) - Location text: Emeryville, CA - Where it can be done from (inferred): Onsite · United States (evidence: "Location: Emeryville, CA") - Posted: 2026-11-02 (10 days ago) - First seen by alder: 2026-11-04 · last verified: 2026-11-10 - Reposted: 0 times · edited: 0 times - Apply on the employer's site: https://jobs.lever.co/5amventures/36bdb00b-62ea-4dcf-b9a4-11dbb95d677d ## Pay and sponsorship - Posted pay: $225k–$275k per year (from the listing's pay field) - Market band for similar posted roles (SF Bay Area, n 1123): p25 $210k, median $250k, p75 $289k ## Description (the employer's text) ### 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. --- Data: alder (https://alderhq.app). Cite https://alderhq.app/jobs/lever%3A5amventures%3A36bdb00b-62ea-4dcf-b9a4-11dbb95d677d and the date you read it. Observed facts come from the employer's own listing; location reach, level, family and skills are inferences.