Director/Senior Director, CMC Quality Operations

🔥 7 minutes ago

🇺🇸 United States – Remote

💵 $200k - $290k / year

⏰ Full Time

🟠 Senior

⚙️ Operations

👻 Ghost score 0%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Faeth Therapeutics

WebsiteLinkedInAll Job Openings

11 - 50 employees

🧬 Biotechnology

💊 Pharmaceuticals

🔥 Funding within the last year

💰 $200M Merger/Acquisition on 2026-02

Biotechnology • Pharmaceuticals

Faeth Therapeutics is a clinical-stage biotechnology company developing oral multi-node inhibitors of the PAM (PI3K/AKT/mTOR) pathway for oncology. Its lead candidate, PIKTOR, is an all-oral combination designed to simultaneously inhibit PI3K-alpha, mTORC1, and mTORC2 to achieve deeper pathway suppression and mitigate tumor escape mechanisms. PIKTOR is being evaluated in multiple cancer indications (including endometrial cancer and HR+/HER2- breast cancer) across Phase 1 and Phase 2 trials. The company emphasizes an oral formulation to reduce infusion-related burdens and focuses on developing novel therapeutics to improve outcomes for patients with hard-to-treat cancers. The drug candidates are investigational and not approved by regulatory authorities.

📋 Description

• 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 and reports. • Review stability protocols and monitor the 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. • Collaborate with CMC and Technical Operations departments. • Report to the SVP, Technical Operations.

🎯 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. • Eligibility to work in the United States.

🏖️ Benefits

• 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

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume