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.
* 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
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
