Senior Director, CMC Quality Operations - Remote

Faeth Therapeutics; Austin (TX); Remote; USD 200,000 - 290,000; Full time

Benefits offered by this job

100% remote work

Flexible schedule

Health, dental, and vision for you and

Generous parental leave

Traditional and Roth 401k

Job summary

Faeth Therapeutics, a Nasdaq-listed clinical-stage oncology company, seeks a Director/Senior Director of CMC Quality Operations. This remote US role collaborates across CMC, Technical Operations, and QA to drive analytical development, QC, and stability at CDMOs, with significant IND/IMPD/NDA/MAA exposure.

You will manage stability programs, method transfer, and regulatory reporting, ensuring cGMP compliance, robust data analysis, and timely regulatory responses.

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 IND/IMPD/BLA/NDA/MAA filings.
• Independently proficient in a variety of analytical techniques for biologic and small molecule development.
• Ability to communicate with vendors on scope, results, and timelines; prioritize to meet goals.
• Thorough understanding of cGMP, USP and ICH guidelines and industry best practices.
• Subject matter expertise in stability program management, data trending, and shelf-life assignments.

Responsibilities

• Manage contract drug substance and drug product analytical development and QC activities and timelines.
• Review analytical method transfer documentation and validation reports.
• Review stability protocols and monitor the stability program.
• Author, review, and approve analytical technical reports.
• Adjudicate CMC sections for US and ex-US regulatory filings; drive CAPAs with QA.
• Direct batch release support and maintain CoAs, CoTs, and specs.
• Lead change controls and investigations to identify root causes and implement corrective actions.

Skills

Analytical Development

Quality Control

Regulatory Knowledge

Vendor Management

cGMP & ICH

Tools

JMP

Veeva Vault

TrackWise

LIMS

Job description

Faeth Therapeutics, a Nasdaq-listed clinical-stage oncology company, seeks a Director/Senior Director of CMC Quality Operations. This remote US role collaborates across CMC, Technical Operations, and QA to drive analytical development, QC, and stability at CDMOs, with significant IND/IMPD/NDA/MAA exposure.

You will manage stability programs, method transfer, and regulatory reporting, ensuring cGMP compliance, robust data analysis, and timely regulatory responses.