Vice President, CMC Technical Operations

Summary

Join Day One Biopharmaceuticals as their Vice President of CMC Technical Operations, a strategic leadership role focused on defining and executing a comprehensive global manufacturing strategy for small molecule and ADC portfolios. You will lead a team, oversee CDMO partnerships, and ensure reliable drug supply. This hands-on position requires expertise in CMC regulatory requirements, process development, and manufacturing site operations. The ideal candidate will have extensive experience in oral small molecules and biologics/ADCs and a proven track record of success. The position offers the potential for remote work with occasional travel and a competitive salary.

Requirements

• Ph.D. in biochemistry, immunology, pharmaceutical sciences, or a related field with at least 15+ years of Operations and Technical Operations experience in an industrial setting
• B.S or M.S. in a relevant field with at least 20+ years of Operations and Technical Operations experience in an industrial setting
• Direct site GM experience, with previous site leadership roles in QA, Manufacturing, and Technical Operations/MS&T
• Extensive expertise in CMC strategy and ADC/Biologics drug development and operations
• Deep expertise in developing, optimizing, troubleshooting, and tech transferring processes for Biologics and/or ADCs
• Significant experience interfacing with and providing effective oversight of GMP operations at CDMOs
• Experienced in technology and/or process transfer for late-stage clinical manufacturing and commercial qualification campaigns
• Knowledge and expertise to solve complex technical problems; may apply novel approach that provides significant technology advancement
• Develop team members, both internally and at selected partners, to continually improve their technical capabilities
• Excellent leadership, communication, and project management skills
• Demonstrated leadership of manufacturing and technical operations both internally and externally
• Generate and analyze data to guide critical decision making within CMC which could include the use of statistical analysis and data mining for trending
• Knowledgeable on current global regulatory requirements and industry
• Excellent verbal and written communication skills with the ability to communicate with vendors, internal teams (including management), and regulators
• Flexible and “hands-on” to navigate between strategic and technical roles
• Able to work in a fast-paced bio-tech environment while managing multiple projects
• Ability to create collaborative and trusting relationships internally and with external partners

Responsibilities

• Develop and execute a comprehensive global manufacturing strategy that aligns with the company's mission and objectives
• Provide expert leadership and strategic direction for CMC-related activities including process development and manufacturing of small molecules and ADCs (Biologics/mAb, conjugation, formulation/sterile filling & lyophilization), overseeing both strategic and executional activities at CDMO partners
• Oversight of CDMO operational execution and technical support. Technical support may include campaign readiness, process changes, complex investigations, and batch release activities
• Define multi-year, continuous improvement plan that drives a continuous improvement culture, outlining initiatives to optimize manufacturing processes, cost-effectiveness, and scalability for commercial production
• Lead and guide next generation process designs and technology transfers for portfolio of products in support of defined lifecycle opportunities (i.e from early clinical phases through global NDA/BLA/MAA filing approvals and post-launch commercial supply network)
• Lead CMC technical due diligence on Business Development opportunities
• Build and develop staff for future roles and career progression
• Ensure a culture of safety and right-first-time Quality
• Establish operational performance measures in partnership with CDMO network for all phases of product lifecycle (i.e. clinical and commercial) and ensure adherence to contractual requirements
• Work closely with the CDMO manufacturing facilities to ensure alignment in process development, scale-up, and manufacturing activities to meet program deliverables and ensure alignment on financial considerations
• Ensure alignment of Day One Bio program needs with CDMO capacity and capabilities, and defining clear points of decision making that requires flexibility in operational deliverables
• Provide leadership to internal team and CDMOs to align on technology transfer plans and ensure consistency and scalability between sites, maintaining high-quality standards and with a clear line of sight to data packages that support regulatory compliance and filing requirements
• Work with team and CDMO technical/MS&T organization on detailed data trend analysis and associated characterization work to be completed in support of process understanding, regulatory reporting and submission, and process improvements
• Day One Bio Product Team member to engage with associated R&D and Commercial functions to establish line of sight to program commercialization and lifecycle management. Lead CMC cross-functional team to establish CMC strategy for program to achieve Target Product Profile (TPP)
• Communication with partners to align on manufacturing feasibility, critical quality attributes (CQAs), and specifications throughout development
• Ensure the integrity, organization, and integration of CMC process development and scale-up datasets in support of regulatory submissions
• Lead team of SMEs to author Module 3 content for BLA submissions and technical responses to Regulatory Authority inquiries. Outline overall strategy for process development/MS&T data packages to meet BLA requirements for BLA submissions. Work closely with regulatory CMC to ensure that Module 3 information meet all regulatory guidelines and are properly represented in regulatory filings
• Implement and maintain processes in communication with CDMOs to ensure compliance with regulatory requirements based on relevant guidance and accepted standard organizations (e.g., USP, EP, JP, etc.)
• Review for IND, BLA, and other regulatory submissions to include all relevant data and documentation in support of clinical/commercial products
• Serve as a key CMC representative in meetings with Regulatory Health Authorities, partners, and internal stakeholders

Preferred Qualifications

Language Skills: Mandarin Chinese is desired but not a requirement to collaborate with China CDMO partners

Benefits

• The salary range for this position is $300,000 - $340,000
• This position has the potential to be fully remote