BlossomHill Therapeutics, Inc. · 6 hours ago
Associate Director, Analytical Development & Quality Control
San Diego, CA, US
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$165K/yr - $195K/yr
7+ years expBlossomHill Therapeutics, Inc. is a company focused on drug development, and they are seeking an Associate Director for Analytical Development and Quality Control. The role involves overseeing analytical activities related to drug substances and products, including method development, validation, and stability testing.
BiopharmaBiotechnologyHealth CareOncologyPharmaceuticalTherapeutics
Responsibilities
Collaboration with CMC functions (drug substance, formulation, and clinical supplies), Regulatory, Pre-Clinical, and Clinical teams
Strong knowledge of regulatory filings (IND, IMPD, NDA, and MAA), specifically Module 3
Work with CDMOs and manage the work to ensure timely completion of deliverables
Conduct stability studies, analyze the data, and assign shelf-life
Set specifications for drug substance and drug product based on available data
Record, analyze, and present data in research group meetings
Qualification
Required
B.S., M.S., or Ph.D. in Analytical Chemistry or related majors (e.g., Chemistry, Physical Chemistry) with 7+ years of experience
Deep knowledge of chromatography (LC and GC) and instruments used for testing of API and drug products including dissolution, mass spectrometry (LC-MS, GC-MS, ICP-MS), titration, Karl Fischer, PXRD, DSC, TGA, FT-IR, PSD, and PLM
Experienced in writing regulatory documents including IND, IMPD, NDA, and MAA
Skilled in stability testing including protocol generation, interpretation of data, and shelf-life assignment
Strong knowledge of drug development phases (pre-clinical through commercial launch)
Experienced in investigations related to deviations and OOT/OOS with excellent collaboration with the Quality Unit
Experienced in vendor auditing and quality risk assessment
Ability to present decision-making data at weekly update and progress reports to project team
Ability to successfully handle multiple tasks and goals with time constraints
Company
BlossomHill Therapeutics, Inc.
BlossomHill Therapeutics, Inc.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$257MKey Investors
BioTrack Capital,Brahma Capital,Janus Henderson InvestorsColt VenturesCormorant Asset Management,OrbiMed,Vivo Capital
2025-12-10Series B· $84M
2024-01-02Series B· $100M
2023-01-01Series Unknown
Leadership Team
Y. Peter Li
Co-Founder
Recent News
BioWorld Financial Watch
2026-01-03
Venture Capital
2025-12-20
Company data provided by crunchbase