Head of Technical Operations

About the Organization

We are a U.S.-headquartered global biopharmaceutical platform advancing next-generation biologics and specialty therapeutics across high-complexity, regulated manufacturing environments. Our portfolio includes late-stage and commercial programs supported by internal GMP capabilities and a global CDMO/CMO partner ecosystem spanning drug substance, drug product, packaging/labeling, and cold-chain distribution.

Operating at the intersection of clinical velocity, regulatory rigor, and supply continuity, we manage tech transfer, process validation, quality-by-design execution, equipment qualification, and manufacturing readiness across multiple sites and external partners. As we scale commercialization timelines, strengthen global supply resilience, and expand into advanced modalities, technical operations become the enterprise engine connecting development, quality, regulatory, and manufacturing into one disciplined execution system.

We are seeking a transformational Head of Technical Operations to lead end-to-end technical operations governance across process scale-up, GMP manufacturing readiness, tech transfer, validation strategy, and cross-site operational performance, fully remote within the United States.

This is not a plant manager role. This is an enterprise-level, cross-network technical execution mandate.

Job Function

The Head of Technical Operations will architect and run enterprise technical operations across internal and external manufacturing networks, ensuring reliable, inspection-ready execution from late-stage development through commercial supply. This executive owns technical readiness, tech transfer governance, process robustness, validation/qualification strategy, deviation/CAPA technical leadership, and operational performance analytics across multi-site GMP manufacturing and CDMO partners.

Essential Duties and Responsibilities

• Lead enterprise Tech Ops strategy aligning manufacturing readiness, process robustness, and supply continuity with clinical-to-commercial timelines.

• Own tech transfer governance across drug substance and drug product programs, establishing stage-gate frameworks, deliverable rigor, and cross-functional accountability.

• Direct process scale-up and validation strategy (PPQ/CPV), ensuring alignment with QbD principles, regulatory expectations, and commercial performance targets.

• Oversee manufacturing technical oversight for internal GMP sites and external CDMO/CMO partners, including performance management, batch success rate, and technical issue resolution.

• Drive equipment qualification and facility readiness (IQ/OQ/PQ), ensuring documentation discipline, audit readiness, and timely release to operations.

• Establish technical deviation and CAPA leadership for complex manufacturing investigations, root-cause analysis, and prevention systems that protect supply and compliance.

• Partner with Quality leadership to ensure inspection readiness, data integrity, and consistent application of GMP principles across the manufacturing network.

• Build operational performance dashboards tracking right-first-time (RFT), OEE, scrap/rework, cycle time, batch release speed, and deviation recurrence.

• Strengthen change control and lifecycle management across process improvements, raw material changes, equipment upgrades, and tech package evolution.

• Lead raw material and critical reagent technical risk mitigation, including supplier qualification support, comparability assessments, and dual-sourcing technical strategy.

• Guide analytical/CMC integration to ensure method readiness, stability strategy alignment, and robust control strategies supporting consistent product quality.

• Scale and mentor Tech Ops leadership (tech transfer, process engineering, validation, MSAT, operational readiness), building a high-accountability culture across distributed teams.

Strategic Support

• Advise executive leadership on manufacturing network strategy, including make/buy decisions, CDMO selection frameworks, and global capacity planning.

• Support regulatory submissions and health authority interactions by ensuring CMC execution, validation packages, and comparability narratives are audit-grade.

• Lead post-merger or partner integration efforts for new manufacturing capabilities, harmonizing standards, documentation, and performance governance.

• Establish a long-horizon roadmap for digital manufacturing modernization (eBR, MES, CPV analytics, deviations automation, data integrity tooling).

• Partner with Supply Chain to strengthen S&OP alignment, cold-chain readiness, and supply continuity planning for launches and demand variability.

• Develop enterprise risk frameworks for inspection outcomes, single points of failure, capacity constraints, and critical-path material dependencies.

Job Qualifications and Requirements

• 15+ years of progressive leadership experience across Technical Operations, MSAT, Process Engineering, Tech Transfer, and/or Validation in GMP environments.

• 8+ years within biopharma, biologics, vaccines, sterile manufacturing, advanced therapeutics, or similarly regulated life sciences manufacturing.

• Demonstrated success leading clinical-to-commercial scale transitions, tech transfers, and validation programs under aggressive timelines.

• Deep working knowledge of GMP, QbD, CPV, PPQ, change control, deviation investigations, and data integrity expectations.

• Proven experience managing and governing CDMOs/CMOs with measurable performance outcomes and inspection readiness.

• Strong cross-functional fluency across Quality, Regulatory Affairs, CMC/Analytical, Supply Chain, and Manufacturing.

• Bachelor’s degree required in Engineering, Chemistry, Biology, or related field; advanced degree strongly preferred.

Personal Capabilities and Qualifications

• Enterprise-level operator with high accountability for compliance, supply reliability, and execution precision

• Systems-oriented leader who can scale governance without slowing speed-to-market

• Strong executive presence with disciplined communication for Board, investor, and audit-facing forums

• Calm under pressure in deviation investigations, launch readiness, and regulatory inspection environments

• Data-driven mindset with the ability to translate technical signals into clear operational decisions

• Exceptional stakeholder alignment across internal teams and external partners

• Builder of strong teams, high standards, and repeatable operational playbooks

Working Conditions

• Remote – United States with frequent travel to GMP sites, CDMOs, and key program reviews (30–45%).

• The role requires availability for time-sensitive manufacturing support across multiple time zones.

• High-accountability position tied to batch success, inspection readiness, validation milestones, and supply continuity.

• Collaboration across distributed R&D/CMC, Quality, Regulatory, Manufacturing, and Supply Chain organizations.

Compensation & Benefits

Total Executive Compensation Package: $345,000 – $438,000 USD

Compensation Includes:

• Competitive base salary within stated range

• Performance-based annual incentive aligned to supply performance, batch success, and milestone execution

• Long-term incentive eligibility (equity and/or executive performance units, where applicable)

• Comprehensive health, dental, and vision coverage

• 401(k) with employer contribution

• Remote work support + executive home office stipend

• Executive leadership development and technical governance resources

• Generous PTO and executive leave structure

Why Join Us

• Lead technical operations for a platform scaling complex therapeutics through clinical acceleration and commercial expansion

• Own the enterprise engine that protects GMP excellence, inspection readiness, and supply continuity

• Influence network strategy across internal sites and global CDMO partners with executive visibility and impact

• Help build repeatable Tech Ops governance that enables faster launches, fewer deviations, and stronger margins

• Competitive executive compensation tied directly to measurable operational outcomes