Sr Director, Technical Operations

• The Senior Director, Technical Operations provides strategic leadership and oversight of drug product manufacturing and external CDMO operations from late-stage development through commercialization. This role is accountable for defining manufacturing strategy, managing increasing operational complexity, and ensuring reliable supply to support both late phase programs and commercial products.
• The Sr. Director will lead resolution of critical drug product manufacturing issues, oversee high-risk operations, and ensure readiness for commercial scale, while partnering cross-functionally across Pharmaceutical Sciences, Analytical Development, Supply Chain, Regulatory and Quality.

Let’s talk about some of the key responsibilities of the role:

• Define and lead end-to-end drug product manufacturing strategy from late phase clinical through commercial stages. Ensure scalability of processes, supply chain, and CMO network to support commercialization growth. Anticipate and manage increasing operational complexity across programs, manufacturing sites and partnerships.
• Provide senior oversight of CDMO relationships, including performance management, capacity planning, and long-term partnership strategy. Establish governance models and develop relationships to ensure accountability, transparency, and execution across external partners. Lead selection, onboarding, and strategic management of CMOs for development and commercial supply.
• Lead resolution of critical manufacturing issues, including deviations, investigations, and high-risk events. Serve as escalation point for complex technical and operational challenges. Develop and implement proactive risk mitigation strategies to ensure continuity of supply.
• Partner cross-functionally with Pharmaceutical Sciences, Analytical Development, Supply Chain, Regulatory and Quality to align CMC strategy and execution. Provide leadership in integrating development, manufacturing, capacity planning and supply planning activities. Influence cross-functional decision-making at the program and organizational level.
• Lead multiple CMC programs, ensuring alignment with regulatory, technical, and corporate strategy. Oversee manufacturing execution at CMOs, including batch strategy, documentation, and compliance. Ensure readiness and contribution to CMC regulatory submissions and inspections.
• Establishes clear ownership and accountability for manufacturing strategy and execution. Enables reliable and scalable supply to support clinical and commercial programs. Reduces operational risk through proactive issue management and decision-making. Serves as a key leader in advancing the organization’s transition to commercial-stage operations.
• Manage Person-in-Plant coverage to provide adequate oversight for manufacturing activities. Develop and manage budget for CMC programs. Collaborate with Finance to address budget variance.

Factors for Success:

• B.S. /M.S./Ph.D. in one of the relevant Engineering or Science fields
• Strong understanding of technical/scientific challenges as those apply to the production processes used in the manufacture of Sterile products and the subsequent packaging of those products.
• 15+ years of progressive responsibility in Technical Operations and/or manufacturing support in pharmaceutical manufacturing. (Doctorate degrees require a minimum of 10 years total experience.)
• Preferable experience in all the following areas:
  Sterile ophthalmic dosage forms, Solid Oral Dose and Packaging and Topical Dermal formulations.
• Must have strong understanding of project management systems and tools, strong business and financial skills.
• Established track record with evidence of excellent people management experience, problem solving, collaborative, leadership and communication…