ArriVent Biopharma · 6 hours ago
Associate Director/Director, Biologics Analytical Development
United States
Full-time
Remote
Lead/Staff, Director/Executive
$200K/yr - $230K/yr
8+ years expArriVent Biopharma is seeking an Associate Director/Director of Biologics Analytical Development to lead analytical activities supporting biologics and antibody-drug conjugate programs. The role involves providing scientific leadership and strategic direction while ensuring robust analytical control strategies aligned with regulatory expectations.
BiotechnologyLife SciencePharmaceutical
Responsibilities
Lead phase-appropriate analytical development strategies for biologics and ADCs (including mAbs, drug substance, and drug product) across the product lifecycle
Design, oversee, and execute analytical method development, qualification, and validation to support IND-enabling through late-stage (Phase 3/BLA) programs
Serve as a subject matter expert in analytical characterization, release, stability, and comparability for biologics and ADCs
Establish and maintain analytical control strategies, including support for comparability assessments related to process changes, scale-up, and site transfers
Act as the analytical lead for CDMO engagements, providing scientific oversight of method development, validation, transfer, and routine testing activities
Manage and assess CDMO analytical performance, ensuring data quality, compliance, timelines, and effective issue resolution
Support method and technical transfer and ensure analytical readiness at CDMOs for clinical and commercial manufacturing
Author, review, and contribute analytical content to CMC sections of regulatory submissions (INDs, IMPDs, BLAs, MAAs)
Lead responses to analytical regulatory inquiries and support health authority interactions, inspections, and audits
Partner cross-functionally with Process Development, Manufacturing, Quality, Regulatory, Clinical, and Supply Chain teams to ensure alignment and execution
Provide analytical governance across internal teams and external partners, including CDMOs and CROs
Drive scientific rigor, operational excellence, and consistent execution as a key contributor to overall CMC and portfolio strategy
Qualification
Required
PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with 8–12+ years of relevant Biotech/Biologics industry experience for Associate Director
Masters in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with 13-18+ years of relevant Biotech/Biologics industry experience for Associate Director
PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with 12–15+ years of relevant Biotech/Biologics industry experience for Director
Masters in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with 20+ years of relevant Biotech/Biologics industry experience for Director
Extensive experience in biologics analytical development, including hands-on or oversight experience with ADCs
Demonstrated experience supporting both early-stage (preclinical/Phase 1) and late-stage (Phase 3/commercial) programs
Proven experience working with CDMOs, including analytical oversight, method transfer, and issue resolution
Direct experience contributing to or leading global regulatory submissions
Prior direct interaction with FDA, EMA, or other global health authorities
Experience operating in a virtual or hybrid CMC development model
Strong knowledge of analytical techniques used for biologics and ADCs, including Chromatography (HPLC/UPLC, SEC, HIC), Electrophoresis (CE-SDS, icIEF), Mass spectrometry, Binding and functional assays
Solid understanding of ICH guidelines, analytical validation, comparability, and lifecycle management
Strong leadership, communication, and stakeholder management skills
Ability to influence and manage external partners without direct authority
Strategic mindset with a willingness to remain technically engaged
Company
ArriVent Biopharma
ArriVent is dedicated to accelerating the global development of innovative biopharmaceutical products.
11-50 employees
Funding
Current Stage
Public CompanyTotal Funding
$455MKey Investors
Silicon Valley BankHillhouse Investment
2025-07-01Post Ipo Equity· $75M
2025-05-12Post Ipo Debt· $75M
2024-01-26IPO
Leadership Team
Bing Yao
CEO and Chairman of Board of Directors
S
Stuart Lutzker
President, Co-Founder and Head of R&D
Recent News
2025-12-24
2025-12-16
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