About this opportunity
Faeth Therapeutics Inc. lists this Director/Senior Director, CMC Quality Operations opportunity in northern, Kentucky. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Director/Senior Director, CMC Quality Operations
Remote
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.
Reports to: SVP, Technical Operations
Location: Remote (U.S.)
What You'll Do
Faeth seeks a motivated, knowledgeable, and hands-on analytical development scientist and quality control professional to manage analytical development, QA/QC, and stability activities at contract manufacturing sites and to contribute to the development of clinical assets and regulatory submissions. This position requires close collaboration with the Drug Substance, Drug Product, and Quality Assurance groups. This candidate should know the various analytical techniques across modalities. In addition, this individual should be experienced in test method development, analytical method transfer, phase-appropriate method validation, and stability program management (including data trending and analysis) for both drug substances and drug products. A thorough understanding of relevant ICH quality guidelines and excellent communication skills (both verbal and written) is required.
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
Who You Are
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.
The po
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.
Position may require some travel
Compensation Range: $200,000 - $290,000 (actual compensation may vary based on experience, qualifications and location)
Working at Faeth
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
We are an equal opportunity employer, and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
All offers of employment are contingent upon satisfactory completion of a background check and verification of eligibility to work in the United States.
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.