Director, Technical Operations, EXM

Technical Operations Director, Drug Substance EXM

An exciting opportunity has arisen for a Director of Technical Operations, EXM Drug substance (DS), to provide strategic and hands‑on technical leadership across our expanding biologics external manufacturing network in the U.S.

• Technical Ownership & Process Stewardship:
  Drive expectations of deep technical understanding of the CMO partner’s manufacturing facilities and equipment at scale and in their MSAT labs; lead receiving unit New Product Introduction & Tech Transfer activities, ensuring a deep understanding of interconnectivity between operations and science, and provide on‑site SME support during PPQ, early production, and throughout commercial manufacture.
• Investigations, RCA & Complex Problem Solving:
  Serve as the technical authority for complex deviations, investigations, root‑cause analysis, change management, and inspection readiness, ensuring scientific rigor and implementation of high‑quality CAPAs.
• Risk Management, Monitoring & Preventive Action:
  Establish and support proactive process monitoring at CMOs pre‑PPQ and throughout the product lifecycle; detect trends at site‑ and cross‑site levels, lead technical risk reviews, and steward product/process and unit‑operation knowledge management.
• Change Control, Validation, QMS and Inspection Readiness:
  Own or coordinate change control strategy and execution for technical changes; support and drive QMS processes including APR/CPV, process validation, deviations, audits/inspections, and regulatory submissions; ensure at‑site technical competencies and succession planning.
• Build strong partnerships across Manufacturing, Quality, Regulatory, Supply Chain, Process Development, and external partners to ensure effective knowledge transfer, aligned decision‑making, and reliable execution across the network.

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

• Minimum of 10 years of relevant experience in biologics drug substance manufacturing, technical operations, process support, or technology transfer within the biopharmaceutical industry.
• Demonstrated 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 for commercial biologics manufacturing.
• Proven ability to lead cross‑functional teams, influence senior stakeholders, and manage technical complexity across internal teams and external manufacturing partners.
• Excellent communication, problem‑solving, and organizational skills, with the ability to operate effectively in a fast‑paced, matrixed, and highly collaborative environment.

• Adaptability, Biological Engineering, Biopharmaceutical Industry, Biopharmaceutics, Biotechnology, Business Process Improvements, Change Agility, Consulting, Engineering Principles, 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

• Medical, dental, vision, and other health insurance
• Retirement benefits including 401(k)
• Paid holidays and vacation
• Compassionate and sick days
• Annual bonus and long‑term incentive potential

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or other applicable legally protected characteristics. For more about your rights, please refer to the EEOC resources.