New · posted Oct 15
Faeth Therapeutics · Biotechnology
Director/Senior Director, CMC Quality Operations
- Remote, US
- Remote
- Full-time
- Director
Open until filled
The role
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 need
- 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
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.
- 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
Pay and benefits
$200,000 – $290,000 a year
Employer providedCompensation Range: $200,000 - $290,000 (actual compensation may vary based on experience, qualifications and location)
Competitive salary and equity in a well-funded, clinical-stage biotech
100%
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
All offers of employment are contingent upon satisfactory completion of a background check and verification of eligibility to work in the United States.
Equal opportunity, accessibility and legal noticesFaeth Therapeutics's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 23% above the US median for Quality Control roles at this level.
This roleEmployer provided
Director roles in the US25 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $200,000 | — | $290,000 |
| All US (middle half) | $186,000 | $198,500 | $240,000 |
This role: Faeth Therapeutics's own published range. Comparisons: the base pay employers published on open Quality Control roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Control
The general path across 275 open Quality Control roles on Regulatory Jobs, with the titles they carry most. Not Faeth Therapeutics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 26 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Lab testing and methods12
- Collaboration and leadership6
- Documentation and SOPs5
- Validation and qualification4
- Investigations and CAPA2
- Regulatory submissions2
- Quality systems and risk2
- GMP and compliance1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- FDAFDA IND(official source, opens in a new tab)Investigational New Drug applications
- FDAFDA NDA(official source, opens in a new tab)New Drug Applications
- FDAFDA BLA(official source, opens in a new tab)Biologics License Applications
- USPUSP compendial chapters(official source, opens in a new tab)Bioburden (USP <61>), endotoxin (USP <85>), TOC (USP <643>) and water testing
Company hiring pulse
Faeth Therapeutics on Regulatory Jobs
- 2
- Open roles
- 2
- Distinct roles
- 1
- Locations
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Director/Senior Director, CMC Quality Operations at Faeth Therapeutics
Open until filled. $200K–$290K a year, employer provided.