Associate Director, External Quality Control

Halozyme is seeking an Associate Director, External Quality Control to provide full range of QC activities supporting ENHANZE programs. The position requires leadership and technical expertise to oversee external QC activities, meet delivery dates, and ensure cGMP requirements at CMOs. The successful candidate will have a strong background in analytical chemistry, microbiology, and technologies for Biologics, with experience working in the pharmaceutical industry in QC and leading reference standard and stability programs.

Requirements

• Minimum of a Bachelor’s degree in a scientific subject area or engineering
• 10 years proven experience in QC, with a combination of education and experience considered
• Solid background in analytical chemistry, microbiology, and technologies for Biologics
• Previous experience working in the pharmaceutical industry in QC
• Demonstrated experience leading reference standard and stability programs
• Expert writing and reviewing regulatory filings with a strong understanding of regulatory requirements
• Detailed understanding of GMPs, ICH guidelines, and regulatory guidelines
• Highly motivated and dedicated individual with the ability to work independently
• Proven ability to work closely with internal departments, partners, and CMOs
• Effective problem solving and negotiation skills to meet business objectives
• Working knowledge and experience in QC assay development, qualification, and validation
• Experience working with external parties (CMOs, Contract Labs)
• Knowledge of software required: Statistical software (e.g. JMP) and QMS (e.g. MasterControl)

Benefits

• Full and comprehensive benefit program
• 401(k) matching
• Employee Stock Purchase Program
• Opportunities to grow in a culture that prioritizes learning, development, and progression
• Tuition reimbursement
• Collaborative and innovative team