Barrington James
Senior Manager/AD/Director Analytical Development
Barrington James, San Francisco, California, United States, 94199
Overview
Senior Manager/AD/Director Analytical Development — I’m partnering with a fast-growing, clinical-stage biotech that is advancing multiple oral solid dose and peptide programs. They are seeking a Manager / Senior Manager / Associate Director of Analytical Development to lead method development and validation activities. The successful candidate will provide direct oversight and strategic management of CDMOs, design and execute robust analytical strategies, and drive method development and validation to ensure quality and regulatory compliance. Key Responsibilities
Own analytical method development and validation for multiple programs, spanning peptides and solid oral dosage forms. Design and implement stability-indicating methods for complex molecules. Lead testing and characterization of oral dosage forms, including dissolution, content uniformity, assay, impurities, hardness/friability, and moisture (LOD/KF). Support CMC strategy and regulatory readiness, providing data and documentation for IND/CTA, NDA, and MAA submissions. Manage method transfer activities to QC or external CRO/CDMOs. Review QC release and stability data to ensure alignment with specifications and regulatory expectations. Collaborate closely with cross-functional teams including Drug Product Development, Formulation, QC, and Regulatory Affairs. Preferred Experience & Qualifications
Advanced degree in Pharmaceutical Sciences, Chemistry, Biochemistry, or related field; PhD preferred but not mandatory. 7+ years of relevant industry experience in analytical development for peptides and oral dosage forms. Hands-on experience with peptide analytics including RP-HPLC/UPLC, LC–MS, peptide mapping, impurity profiling, and identity confirmation. Proven track record in method development, optimization, and validation per ICH guidelines. Experience supporting tablet and solid oral dosage testing, including specification development and method robustness. Experience with method transfer and managing analytical CRO/CDMO partners. Strong understanding of how analytical methods support QC release, stability, and regulatory submissions. Apply today or Reach out directly to rbanton@barringtonjames.com
#J-18808-Ljbffr
Senior Manager/AD/Director Analytical Development — I’m partnering with a fast-growing, clinical-stage biotech that is advancing multiple oral solid dose and peptide programs. They are seeking a Manager / Senior Manager / Associate Director of Analytical Development to lead method development and validation activities. The successful candidate will provide direct oversight and strategic management of CDMOs, design and execute robust analytical strategies, and drive method development and validation to ensure quality and regulatory compliance. Key Responsibilities
Own analytical method development and validation for multiple programs, spanning peptides and solid oral dosage forms. Design and implement stability-indicating methods for complex molecules. Lead testing and characterization of oral dosage forms, including dissolution, content uniformity, assay, impurities, hardness/friability, and moisture (LOD/KF). Support CMC strategy and regulatory readiness, providing data and documentation for IND/CTA, NDA, and MAA submissions. Manage method transfer activities to QC or external CRO/CDMOs. Review QC release and stability data to ensure alignment with specifications and regulatory expectations. Collaborate closely with cross-functional teams including Drug Product Development, Formulation, QC, and Regulatory Affairs. Preferred Experience & Qualifications
Advanced degree in Pharmaceutical Sciences, Chemistry, Biochemistry, or related field; PhD preferred but not mandatory. 7+ years of relevant industry experience in analytical development for peptides and oral dosage forms. Hands-on experience with peptide analytics including RP-HPLC/UPLC, LC–MS, peptide mapping, impurity profiling, and identity confirmation. Proven track record in method development, optimization, and validation per ICH guidelines. Experience supporting tablet and solid oral dosage testing, including specification development and method robustness. Experience with method transfer and managing analytical CRO/CDMO partners. Strong understanding of how analytical methods support QC release, stability, and regulatory submissions. Apply today or Reach out directly to rbanton@barringtonjames.com
#J-18808-Ljbffr