[Hiring] Director/Senior Director, CMC Quality Operations @Faeth Therapeutics

Role Description

We are looking for a highly self-motivated Director/Senior Director of CMC Quality Operations to join our team. This position will collaborate with various departments of CMC and Technical Operations. This is a unique opportunity to join our team and help build a new generation of therapeutic interventions for cancer.

Reports to: SVP, Technical Operations

Location: Remote (U.S.)

What You'll Do

• Manage contract drug substance and drug product analytical development and quality control activities and timelines
• Review analytical method transfer documentation
• Review analytical method validation protocols/reports
• Review stability protocols and monitor stability program
• Author, review, and approve analytical technical reports
• Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings
• Collaborate with Quality Assurance to close investigations and deviations
• Manage reference standards and critical reagents programs, including qualification, re-testing strategies, and bridging activities across CDMOs
• Direct batch release support by reviewing and approving sampling plans and analytical data; generate and maintain CoAs, CoTs, and product specifications
• Partner with QA to manage change controls; lead OOS/OOT and deviation investigations to identify root causes and implement CAPAs
• Develop, revise, and approve SOPs and QC processes, enhancing compliance, consistency, and operational efficiency

Qualifications

• At least 12 years of experience in Analytical Development and/or Quality Control in a pharmaceutical setting
• Familiarity with CMC analytical regulatory requirements and authoring of IND/IMPD/BLA/NDA/MAA filings and responses to regulatory inquiries
• Independently proficient in a variety of analytical techniques in support of biologic and small molecule development
• Ability to communicate effectively with vendors regarding project scope, scientific results, and project updates
• Ability to understand project timelines and appropriately prioritize activities to achieve project goals
• Thorough understanding of cGMPs, USP and ICH guidelines, and industry best practices
• Subject matter expertise in stability program management, including protocol design, data trending and analysis (e.g., using JMP), and shelf-life assignment/extension
• Proficient with enterprise quality management systems such as Veeva Vault, TrackWise, and LIMS
• Ability to adapt to changes in priorities on short notice
• Ability to make decisions independently under tight timelines
• Position may require some travel

Benefits

• Competitive salary and equity in a well-funded, clinical-stage biotech
• 100% remote work and flexible schedule
• Health, dental, and vision for you and your dependents
• Flexible time off
• Generous parental leave
• Traditional and Roth 401k
• Mission oriented, remote first culture