Director/Senior Director, CMC Quality Operations

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the analytical development and quality control activities for contract drug substances and drug products, ensuring adherence to timelines.

• Evaluate documentation related to analytical method transfers.

• Assess analytical method validation protocols and their corresponding reports.

• Review stability protocols and supervise the stability program.

• Write, assess, and authorize analytical technical reports.

• Create, review, and approve relevant CMC sections for regulatory submissions in the US and internationally.

• Work in conjunction with Quality Assurance to resolve investigations and deviations.

• Manage programs for reference standards and critical reagents, including qualification, re-testing strategies, and coordination across CDMOs.

• Provide support for batch release by reviewing and approving sampling plans and analytical data; generate and maintain Certificates of Analysis (CoAs), Certificates of Testing (CoTs), and product specifications.

• Collaborate with QA to oversee change controls; lead investigations into Out of Specification (OOS)/Out of Trend (OOT) results and deviations to determine root causes and implement Corrective and Preventive Actions (CAPAs).

• Develop, amend, and authorize Standard Operating Procedures (SOPs) and quality control processes to improve compliance, consistency, and operational efficiency.

• Collaborate with the CMC and Technical Operations teams.

• Report directly to the Senior Vice President of Technical Operations.

⛳️ Requirements

• Minimum of 12 years of experience in Analytical Development and/or Quality Control within the pharmaceutical industry.

• Knowledge of CMC analytical regulatory standards and experience in authoring IND/IMPD/BLA/NDA/MAA submissions and responding to regulatory inquiries.

• Independently skilled in diverse analytical techniques supporting both biologic and small molecule development.

• Strong communication skills for engaging with vendors about project scope, scientific findings, and updates.

• Capability to comprehend project timelines and effectively prioritize tasks to meet project objectives.

• Deep understanding of current Good Manufacturing Practices (cGMPs), USP, ICH guidelines, and industry best practices.

• Expertise in managing stability programs, including protocol design, data trending and analysis (e.g., utilizing JMP), and shelf-life assignment/extension.

• Familiarity with enterprise quality management systems such as Veeva Vault, TrackWise, and LIMS.

• Ability to swiftly adapt to shifting priorities when necessary.

• Competence in making independent decisions under time constraints.

• This position may involve some travel.

• Must be eligible to work in the United States.

🏝️ Benefits

• Competitive salary along with equity in a well-supported, clinical-stage biotech company.

• Fully remote work environment with a flexible schedule.

• Comprehensive health, dental, and vision coverage for you and your dependents.

• Flexible time off policy.

• Generous parental leave benefits.

• Options for Traditional and Roth 401k plans.

• Mission-driven, remote-first company culture.