Director, CMC Quality Operations — Remote

Faeth Therapeutics Inc.; Northern (KY); Hybrid; USD 200,000 - 290,000; Full time

Benefits offered by this job

100% remote work

Competitive salary and equity

Health, dental, and vision

Flexible time off

Generous parental leave

Traditional and Roth 401k

Remote-first culture

Job summary

Faeth Therapeutics is seeking a Director/Senior Director of CMC Quality Operations to lead analytical development, QA/QC, and stability activities at CDMOs while collaborating with Drug Substance, Drug Product, and QA teams. This remote role supports regulatory readiness for US assets.

The ideal candidate has 12+ years in Analytical Development or QC, strong cGMP/ICH knowledge, and experience with IND/IMPD/NDA/MAA submissions, multiple analytical techniques, and QMS systems (Veeva Vault,

Qualifications

• 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 IND/IMPD/BLA/NDA/MAA filings.
• Independently proficient in a variety of analytical techniques for biologic and small molecule development.
• Ability to communicate with vendors about scope, results and timelines; prioritize activities.
• Thorough understanding of cGMPs, USP and ICH guidelines and industry best practices.
• Expertise in stability program management, including design, data trending, and shelf-life decisions ( JMP ).
• Proficiency with enterprise QMS such as Veeva Vault, TrackWise, and LIMS.
• The position may require travel.

Responsibilities

• Management of contract drug substance and drug product analytical development and QC 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 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 across CDMOs
• Direct batch release support by reviewing sampling plans and analytical data; generate CoAs and product specifications
• Lead change controls; investigate OOS/OOT and deviations; implement CAPAs
• Develop, revise, and approve SOPs and QC processes

Skills

Analytical Development

Quality Control

CMC Regulatory

IND filings

Stability program management

JMP data analysis

Vendor collaboration

GxP Knowledge

Veeva Vault

TrackWise

LIMS

Tools

Veeva Vault

TrackWise

LIMS

Job description

Faeth Therapeutics is seeking a Director/Senior Director of CMC Quality Operations to lead analytical development, QA/QC, and stability activities at CDMOs while collaborating with Drug Substance, Drug Product, and QA teams. This remote role supports regulatory readiness for US assets.

The ideal candidate has 12+ years in Analytical Development or QC, strong cGMP/ICH knowledge, and experience with IND/IMPD/NDA/MAA submissions, multiple analytical techniques, and QMS systems (Veeva Vault,