Senior Specialist, Quality Control Analytical (Biotech)

Location: On site in El Segundo, California, United States

Annual base pay: $115,000–$128,000, depending on qualifications, experience, and geographic location. The position is also eligible for a discretionary bonus and equity award.

Company

hirify.global is a publicly traded commercial-stage biotechnology company developing immunotherapies, cell therapies, cancer vaccines, and treatments for infectious diseases.

What you will do

• Serve as a subject matter expert for analytical method development, validation, transfer, troubleshooting, and quality investigations.
• Author and review SOPs, analytical methods, protocols, reports, specifications, and other quality documentation.
• Review stability and lot release data, data integrity checks, certificates of analysis, out-of-specification investigations, and invalid laboratory results from contract testing laboratories.
• Update analytical sections of IND and BLA regulatory CMC submissions and support audits and regulatory inspections.
• Manage supplier change notifications, change controls, purchase requisitions, and purchase orders.
• Collaborate with Quality Assurance, Regulatory, contract laboratories, consultants, and other internal departments.

Requirements

• Bachelor’s degree with 8+ years of relevant experience, or master’s degree with 6+ years of relevant experience.
• 6+ years of experience in analytical chemistry or a related discipline.
• Strong knowledge of analytical method development, validation, and transfer.
• Experience with technical writing for analytical test methods, qualification and validation protocols, and reports.
• Knowledge of USP, EP, ICH guidelines, GMPs, and pharmaceutical regulations.
• Ability to work on site in an onsite laboratory environment, including use of appropriate PPE and lifting materials up to 20 pounds.

Nice to have

• Experience with lot release testing, stability programs, and specification development.

Culture & Benefits

• Collaborative environment with opportunities to work across different areas of the company.
• Professional development opportunities in a growing biotechnology company.
• Medical, dental, and vision plan options, health and financial wellness programs, and an employee assistance program.
• 401(k) retirement plan with company match, flexible spending accounts, life and disability coverage, and education savings program.
• Paid time off, holidays, health pay, personal days, cultural days, and additional employee discounts and perks.
• Regular Monday–Friday schedule during standard business hours, with manager-approved flexibility and occasional off-hours work to meet deadlines.