Senior Manager/AD/Director Analytical Development jobs in United States
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Barrington James · 1 day ago

Senior Manager/AD/Director Analytical Development

positionSan Francisco Bay Area
timeFull-time
remoteHybrid
senioritySenior Level, Lead/Staff, Director/Executive
date7+ years exp

Barrington James is 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, ensuring quality and regulatory compliance.

Health CareRecruiting
Hiring Manager
Ryan Banton
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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

Qualification

Analytical method developmentPeptide analyticsMethod validationRegulatory complianceMethod transferCollaborationProject management

Required

Direct oversight and strategic management of CDMO's
Design and execute robust analytical strategies
Drive method development and validation to ensure quality and regulatory compliance
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

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

Company

Barrington James

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Barrington James has a true global reach, with its international HQ in London-Gatwick, continental hubs in Singapore.
dateFounded in 2002
location
New York, New York, USA
people-size201-500 employees
web-link
https://barringtonjames.com/

Funding

Current Stage
Growth Stage
Total Funding
unknown
Key Investors
Orangewood Partners
2022-10-05Private Equity

Recent News

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Weekly Pharma & Life Science News Round-Up: 10th-14th October
2022-10-14
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Orangewood Partners Makes Strategic Investment in Barrington James
2022-10-06
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