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Position Summary:

The Associate Director, Drug Substance Manufacturing - Upstream Process will report to the VP, Commercial Manufacturing Operations and will be responsible all aspects of Drug Substance (DS) biologics manufacturing with expertise in upstream processing.  The individual will serve as a subject matter expert (SME) in upstream processes for outsourced drug-substance manufacturing, technology transfer, life cycle management, and global regulatory submissions of complex Biologics, monoclonal antibodies, and other recombinant therapeutics.

Working with the CMC team and other key functions such as project management, QA and Regulatory, the ideal candidate must be an outstanding leader with a proven track record of overseeing all drug-substance upstream manufacturing activities at the CMO site, including process scale-up, technology transfers, validations, PPQ campaign support, continuous process improvements, and post-approval lifecycle management of commercially approved products. In addition, the role requires authoring, reviewing, and editing of CMC related regulatory submissions (e.g., BLA, MAA) and associated quality documents. The candidate must have exceptional organizational and communication skills, be capable of communicating strategic plans to upper management, summarize data, and effectively manage interactions with stakeholders across functions.

Responsibilities:

Technical Oversight & Manufacturing Support

• Serve as primary technical interface with global CMOs supporting Drug Substance manufacturing upstream activities.
• Lead investigations for technical deviations, root cause analyses, and CAPA implementation.
• Supervise campaign readiness, change management, and process optimization discussions.
• Lead internal technical meetings and contribute to managing timelines, supply impact, risks, and budget. 

Technology Transfer & Validation

• Oversee technology transfer and process qualification across CMO sites.
• Author and review validation protocols, reports, and technical documentation.
• Drive continuous improvement initiatives across upstream processes.
• Drive industry benchmarking and knowledge-sharing across teams.

Lifecycle Management & CPV

• Perform statistical analysis on campaign data to create and analyze process trends and control charts.
• Develop near-term and long-term lifecycle management / process improvement strategies.  Facilitate execution utilizing digital tools (e.g., big data modelling tools), as applicable, for commercial products across manufacturing sites.
• Establish and maintain robust process monitoring and Continuous Process Verification (CPV) protocols /procedures. 

CMC & Regulatory Support

• Author and review CMC sections for global regulatory submissions (NDA, BLA, MAA).
• Support filing in new markets and conduct impact assessment to postapproval changes.
• Support responses to health authority questions related to manufacturing processes and controls.
• Ensure manufacturing and validation strategies align with GMP, ICH, and global regulatory expectations.
  

Qualifications:

• MS in relevant life sciences or engineering discipline with a minimum of 5 years of Pharmaceutical/Biotechnology industry experience (or BS with 8 years of experience) in biologics drug substance upstream processes, technology transfer, and cGMP manufacturing operations.
• Experience in process development and/or manufacturing sciences and technology (MSAT) is preferred.
• Extensive hands-on experience in upstream processing including cell bank management, cell culture (expansion and production), and harvest.
• Working knowledge of technology transfer, process validation, and routine management of GMP manufacturing.
• Experience in managing US/international CDMOs to help support commercial manufacturing of biologic drugs.
• Proven leadership and cross-functional management of CMC-related programs. Track record of successfully driving and managing programs, overcoming challenges, and managing risks.
• Critical thinking and problem-solving skills with ability to drive risk-based decision making.
• Strong organizational and project management skills, including proficient use of MS Project and other tools.
• Excellent communication and interpersonal skills in working across the organization.