Associate Director, Analytical Development & Quality Control

BLOSSOMHILL THERAPEUTICS INC • San Diego, CA

8h

About The Position

The Associate Director, AD/QC will be responsible for analytical activities related to drug substance and drug product. These activities include method development, method validation, method transfer, stability testing and evaluation.

Requirements

• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree