Director/Senior Director, CMC Quality Operations (Biotech)

Location: Remote within the United States; some travel may be required. Eligibility to work in the United States is required.

Compensation: $200,000–$290,000 annually, depending on experience, qualifications, and location.

Company

hirify.global Therapeutics is a clinical-stage oncology biotech company developing PIKTOR, a multi-node PI3K/AKT/mTOR inhibitor program.

What you will do

• Manage analytical development and quality control activities, timelines, and deliverables at contract drug substance and drug product manufacturing sites.
• Review analytical method transfer documents, validation protocols and reports, stability protocols, and analytical technical reports.
• Monitor stability programs, including protocol design, data trending, analysis, and shelf-life assignment or extension.
• Author, review, and adjudicate CMC sections for US and ex-US regulatory filings and responses.
• Support batch release by reviewing sampling plans and analytical data and maintaining certificates, specifications, and reference standards programs.
• Partner with Quality Assurance on investigations, deviations, OOS/OOT events, change controls, CAPAs, SOPs, and QC processes.

Requirements

• At least 12 years of Analytical Development and/or Quality Control experience in a pharmaceutical setting.
• Experience with CMC analytical regulatory requirements and authoring IND, IMPD, BLA, NDA, and MAA filings and responses.
• Proficiency in analytical techniques supporting biologic and small molecule development.
• Strong understanding of cGMPs, USP, ICH guidelines, and industry best practices.
• Expertise in stability program management, including data trending and analysis using tools such as JMP.
• Experience with Veeva Vault, TrackWise, LIMS, vendor management, and independent decision-making under tight timelines.

Culture & Benefits

• 100% remote work with a flexible schedule.
• Health, dental, and vision coverage for employees and dependents.
• Flexible time off and generous parental leave.
• Traditional and Roth 401(k) plans.
• Salary and equity in a well-funded, clinical-stage biotech company.