Director, Technical Operations, EXM

Technical Operations Director, Drug Substance EXM

An exciting opportunity for a Director of Technical Operations to lead the expanding biologics external manufacturing network in the US. This role reports to the Head of Biologics Technical Operations DS and sets the standard for technical excellence across technology transfer, commercialization, and sustained manufacturing performance.

• Technical Ownership & Process Stewardship
  • Drive expectations of deep technical understanding of CMO partner's facilities and equipment at scale and in MSAT labs, achieved through on‑site presence.
  • Lead receiving unit New Product Introduction & Tech Transfer activities, ensuring deep understanding of interconnectivity between operations and the science behind products.
  • Serve as process equipment SME for accountable sites, connected to the network of similar tech ops teams.
  • Provide on‑site SME support during PPQ, early production and throughout commercial manufacture; act as escalation point for multi‑site issues.
  • Support health authority interaction (queries and audits) affecting site activities.
  • Actively support commercialization teams in representing facility & operational considerations during development.
  • Drive product life‑cycle management – develop and implement process changes to ensure long‑term product robustness and compliance, and drive productivity via MPS.
  • Build strong partnerships across Manufacturing, Quality, Regulatory, Supply Chain, Process Development, and external partners for effective knowledge transfer.
• Investigations, RCA & Complex Problem Solving
  • Serve as technical authority for complex deviations, investigations, root cause analysis, change management, and inspection readiness.
  • Feed learnings from supply production into development teams and across Operations teams.
• Risk Management, Monitoring & Preventive Action
  • Establish and support proactive process monitoring at CMOs pre‑PPQ and throughout the product lifecycle.
  • Detect trends at site, cross‑site, and cross‑program; sustain or improve performance; lead technical risk reviews.
  • Own stewardship of product/process and unit‑operation knowledge management.
• Change Control, Validation, QMS and Inspection Readiness support
  • Own or coordinate change control strategy and execution for technical changes.
  • Support/drive QMS processes: APR/CPV, process validation, deviations, audits/inspections, regulatory submissions.
  • Ensure right level of at‑site technical competencies and succession planning.
  • Support adoption of business process improvement efforts and identify opportunities for streamlining.

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, Biotechnology, Biology, Chemistry, or a related scientific discipline.
• Advanced degree preferred.

• 10+ years of relevant experience in biologics drug substance manufacturing, technical operations, process support, or technology transfer within the biopharmaceutical industry.
• Experience leading technology transfer and receiving‑unit readiness activities for late‑stage clinical or commercial biologics programs.
• Strong knowledge of cGMP manufacturing, process validation, quality systems, deviation management, investigations, and regulatory expectations.
• Proven ability to lead cross‑functional teams, influence senior stakeholders, and manage technical complexity.
• Excellent communication, problem‑solving, and organizational skills in a fast‑paced, matrixed, collaborative environment.

• Adaptability
• Biological/Pharmaceutical Engineering
• Business Process Improvement
• Change Agility
• Consulting
• Engineering Principle
• Fast‑Paced Environments
• Investigative Skills
• Lean Six Sigma Continuous Improvement
• Manufacturing Scale‑Up
• Organizational Capability
• People Leadership
• People Performance Management
• Pharmaceutical Biology
• Process Characterization
• Process Improvements
• Risk Management
• Strategic Thinking
• Technical Leadership
• Technical Operations
• Technology Transfer

• Location requirement: US and Puerto Rico residents only.
• Salary range: $ – $.
• Annual bonus and long‑term incentive, if applicable.
• Benefits: medical, dental, vision, other insurance, retirement (401(k)), paid…