Remote Senior Director, CMC Quality & Analytical Operations

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

Benefits offered by this job

Competitive salary

100% remote work

Health, dental & vision coverage

Flexible time off

Parental leave

401k

Job summary

Faeth seeks a motivated analytical development scientist and quality control professional to manage analytical development, QA/QC, and stability activities at contract manufacturing sites and support regulatory submissions.

The role requires extensive cGMP experience, method development and transfer, stability program management, and collaboration with QA, Drug Substance, and Drug Product teams. Remote (U.S.) with potential travel.

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/MAA filings and responses to regulatory inquiries
• Independently proficient in a variety of analytical techniques for biologic and small molecule development.
• Ability to communicate effectively with vendors, manage timelines and priorities.
• Thorough understanding of cGMPs, USP and ICH guidelines, and industry best practices.

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 across CDMOs
• Direct batch release support by reviewing sampling plans and analytical data; generate 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 and efficiency

Skills

Analytical Development

Quality Control

Regulatory Submissions

Team Collaboration

cGMP compliance

Data interpretation

Tools

JMP

Veeva Vault

TrackWise

LIMS

Job description

Faeth seeks a motivated analytical development scientist and quality control professional to manage analytical development, QA/QC, and stability activities at contract manufacturing sites and support regulatory submissions.

The role requires extensive cGMP experience, method development and transfer, stability program management, and collaboration with QA, Drug Substance, and Drug Product teams. Remote (U.S.) with potential travel.