Manufacturing PM

Senior Director / Executive Director, Program Leadership & Technical Operations (Contract – 12 Months)

Location: Redwood City, CA (Hybrid Preferred)

Duration: 12-Month Contract

Position Overview

We are seeking an experienced Program Leadership and Technical Operations consultant to support a late-stage gene therapy program progressing toward commercialization. This individual will serve as a strategic cross-functional leader responsible for driving program execution across CMC, Technical Operations, Manufacturing, Analytical Development, Quality, Regulatory, and external CDMO partners.

The ideal candidate will bring 12–18 years of biopharmaceutical industry experience with demonstrated success leading complex biologics or gene therapy programs from clinical development through regulatory submission, process validation, and commercial readiness activities.

This role will operate at the intersection of program leadership, CMC strategy, technical operations, and external manufacturing oversight, ensuring alignment across internal stakeholders and external partners while driving key milestones toward BLA and launch readiness.

Key Responsibilities

• Lead integrated cross-functional program execution across Technical Operations, Manufacturing, MSAT, Process Development, Analytical Development, Quality, Regulatory Affairs, Supply Chain, and Clinical Operations.
• Develop and maintain integrated development plans, timelines, budgets, risk assessments, and mitigation strategies.
• Drive CMC governance, accountability, and milestone execution across late-stage development and commercialization activities.
• Provide strategic oversight of external CDMOs supporting process characterization, validation, manufacturing, analytical testing, and technology transfer activities.
• Partner with Technical Operations leadership to support process performance qualification (PPQ), validation readiness, inspection readiness, and commercial manufacturing strategies.
• Coordinate preparation and execution of major regulatory submissions, including IND amendments, BLAs, and global health authority interactions.
• Lead cross-functional issue resolution and facilitate executive-level decision making through clear communication of risks, dependencies, and mitigation plans.
• Support commercial readiness initiatives including supply planning, launch planning, lifecycle management, and post-approval change strategies.
• Ensure alignment between development, quality, regulatory, and manufacturing organizations to achieve program objectives.
• Provide leadership during governance meetings, program reviews, and interactions with senior executives.

Required Qualifications

• Bachelor's degree in Biochemistry, Biology, Chemical Engineering, Pharmaceutical Sciences, or related scientific discipline.
• 12–18 years of experience within biotechnology or pharmaceutical development.
• Demonstrated experience leading complex cross-functional development programs from clinical development through regulatory submission and commercialization.
• Strong knowledge of CMC development, manufacturing operations, technical operations, and regulatory requirements.
• Experience managing external CDMOs and global manufacturing networks.
• Proven success supporting IND, CTA, BLA, MAA, or NDA submissions.
• Expertise in risk management, integrated development planning, and executive stakeholder communication.
• Ability to influence across functions without direct authority in a fast-paced development environment.

Preferred Qualifications

• Direct experience supporting AAV gene therapy, cell therapy, viral vector, or advanced therapeutic programs.
• Experience leading late-stage clinical or commercial readiness initiatives.
• Strong understanding of process characterization, validation, technology transfer, PPQ, and lifecycle management.
• Experience supporting FDA, EMA, MHRA, PMDA, or other global regulatory interactions.
• Prior Program Team Leader, CMC Leadership, Technical Operations Leadership, or Portfolio Management experience.
• Experience supporting commercial launch planning and post-approval manufacturing strategies.

Ideal Background

• Gene Therapy Program Leadership
• Technical Operations Leadership
• CMC Program Management
• Manufacturing & Supply Chain Strategy
• Regulatory Submission Planning
• CDMO Management
• BLA Readiness
• Commercial Readiness
• Process Validation & Tech Transfer
• Cross-Functional Executive Leadership