Director/Senior Director, CMC Quality Operations

Faeth Therapeutics•Austin, TX

7d•$200,000 - $290,000•Remote

About The Position

Faeth Therapeutics is a clinical-stage oncology company listed on Nasdaq that recently raised $200M in funding. With a strong scientific foundation and a founding team that includes the discoverer of our target pathway, we are advancing PIKTOR, a multi-node PI3K/AKT/mTOR inhibitor program, toward multiple near-term milestones. We are a small, focused team where every person has direct impact — united by a shared commitment to care deeply, create boldly, and never stop learning. 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.

Requirements

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.
Position will require an ability to adapt to changes in priorities on short notice and will also require an ability to make decisions, independently, under tight timelines.

Nice To Haves

Position may require some travel

Responsibilities

Management of 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