Analytical Development – Manager/Sr. Manager

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

📋 Description

• Supervise contract development and manufacturing organizations (CDMOs) to oversee analytical development and quality control (QC) activities for drug substance (DS) and drug product (DP).

• Manage analytical documentation (such as Certificates of Analysis, test methods, protocols, reports, specifications, stability data, and raw data) within the Quality Management System (QMS).

• Support and draft analytical content for CMC Regulatory submissions for both U.S. and international dossiers.

• Oversee GMP stability studies and provide trend analysis to support retesting and shelf-life extensions.

• Manage the reference standard program, including qualification, storage, inventory, and distribution.

• Develop and approve specifications for raw materials, intermediates, and finished products, while being knowledgeable about regulatory requirements for setting specifications.

• Develop and validate analytical methods and verify compendial methods.

• Effectively communicate results both internally and externally through oral and written updates and formal reports as needed.

• Provide analytical support for API and Drug Product process development.

• Author development reports, protocols, and methods.

• Assist with quality audits as a technical representative and contribute to the writing of audit reports.

⛳️ Requirements

• Minimum of 7 years of experience in analytical development within a pharmaceutical environment.

• Demonstrated leadership experience in managing analytical chemists at various levels, particularly in external settings (CMO management).

• Independently skilled in a range of analytical techniques and regulatory areas, including but not limited to HPLC, LC/MS, GC, GC/MS, USP dissolution testing apparatus, pH meters, UV/Vis spectroscopy, KF, and phase-appropriate analytical method validation.

• Knowledge and direct experience with CMC analytical regulatory requirements, including authoring IND/IMPD filings and responding to regulatory inquiries; experience in applying regulatory guidelines (ICH, FDA, EMA, etc.) to pharmaceutical development and CMC strategy.

• Ability to communicate effectively with vendors regarding project scope, scientific results, and project updates, along with the capability to understand project timelines and prioritize activities to meet project objectives.

• The role requires adaptability to changes in priorities on short notice and the ability to make independent decisions under tight deadlines.

• Willingness to travel up to 20%.

🏝️ Benefits

• Competitive compensation package.

• 401(k) plan with employer matching.

• Employee Stock Purchase Program (ESPP).

• Pre-tax commuter benefits for transit and parking.

• Referral bonuses for successful candidate placements.

• Subsidized meals and parking on in-office days.

• Comprehensive medical, dental, and vision coverage fully paid by the employer for you and your dependents.

• Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA).

• Fertility and family-forming benefits.

• Expanded mental health support, including therapy and coaching resources.

• Hybrid work model with flexible arrangements.

• Flexible paid time off policy with “take-what-you-need” options and company-paid holidays.

• Comprehensive paid medical and parental leave to support personal and family needs.