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About the Role
Faeth Therapeutics is seeking a highly self-motivated Director/Senior Director of CMC Quality Operations to manage analytical development, QA/QC, and stability activities at contract manufacturing sites. This role is crucial for advancing clinical assets and supporting regulatory submissions, offering a unique opportunity to contribute to a new generation of cancer therapeutics.
Responsibilities
- 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.
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.
- Ability to adapt to changes in priorities on short notice.
- Ability to make decisions independently under tight timelines.
- Position may require some travel.
Skills
- Analytical Development
- Quality Control
- Analytical Techniques
- Test Method Development
- Analytical Method Transfer
- Phase-appropriate Method Validation
- Stability Program Management
- Data Trending and Analysis
- ICH Quality Guidelines
- Verbal Communication
- Written Communication
- JMP
- Veeva Vault
- TrackWise
- LIMS
Location
- Remote (U.S.)
Work Type
- Remote
- Full-time
Experience Level
- Director/Senior Director
- At least 12 years
Salary/Compensations
- $200,000 - $290,000
Benefits
- Competitive salary and equity
- 100% remote work
- 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
About the Company
- Faeth Therapeutics is a clinical-stage oncology company listed on Nasdaq that recently raised $200M in funding.
- We have 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.
Equal Opportunity
- 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.