Associate Director, Drug Substance Manufacturing – Upstream Process

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

📋 Description

• Act as the subject matter expert in upstream processes related to outsourced drug-substance manufacturing, technology transfer, lifecycle management, and global regulatory submissions for intricate biologics, monoclonal antibodies, and recombinant therapeutics.

• Function as the primary technical liaison with global CMOs overseeing drug substance upstream operations.

• Direct technical deviation investigations, root cause analyses, and implementation of CAPA.

• Manage campaign readiness, change management, and discussions on process optimization.

• Lead internal technical meetings and assist in managing timelines, supply impacts, risks, and budget considerations.

• Supervise technology transfer and process qualification at various CMO sites.

• Draft and review validation protocols, reports, and technical documentation.

• Propel continuous improvement initiatives, industry benchmarking, and knowledge-sharing across teams.

• Conduct statistical analyses on campaign data to identify and evaluate process trends and control charts.

• Formulate lifecycle management and process enhancement strategies, facilitating execution through digital tools.

• Establish and uphold protocols and procedures for process monitoring and Continuous Process Verification (CPV).

• Write and review CMC sections for NDA, BLA, and MAA submissions.

• Assist in new-market filings, post-approval change impact assessments, and responding to inquiries from health authorities.

• Ensure that manufacturing and validation strategies are compliant with GMP, ICH, and global regulatory standards.

• Report to the VP of Commercial Manufacturing Operations and collaborate with CMC, project management, QA, and Regulatory teams.

⛳️ Requirements

• MS in a relevant life sciences or engineering field with at least 5 years of experience in the Pharmaceutical/Biotechnology industry, specifically in biologics drug substance upstream processes, technology transfer, and cGMP manufacturing operations; or a BS with 8 years of experience.

• Preferred experience in process development and/or manufacturing sciences and technology (MSAT).

• Significant hands-on experience in upstream processing, which includes cell bank management, cell culture (expansion and production), and harvesting.

• Familiarity with technology transfer, process validation, and routine management of GMP manufacturing practices.

• Experience in managing US/international CDMOs to facilitate the commercial manufacturing of biologic drugs.

• Demonstrated leadership and cross-functional management skills in CMC-related programs.

• Proven record of successfully directing and managing programs, navigating challenges, and mitigating risks.

• Strong critical thinking and problem-solving abilities with a focus on risk-based decision making.

• Excellent organizational and project management capabilities, with proficient use of MS Project and other relevant tools.

• Outstanding communication and interpersonal skills for effective collaboration across the organization.

🏝️ Benefits

• Annual performance incentive bonus.

• New hire equity.

• Ongoing performance-based equity.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401k match.

• Flexible time off.

• Paid holidays.