THE OPPORTUNITY

 ESSENTIAL DUTIES & RESPONSIBILITIES:

• Provide leadership for Technical Operations programs and external manufacturing activities, establishing strategy, priorities, scope, timelines, deliverables, responsibilities, budgets, risks, and key decision points.
• Own senior-level Technical Operations relationships with key CMOs/CDMOs and other external partners; establish governance, performance expectations, escalation pathways, and accountability for delivery against manufacturing and business commitments.
• Provide technical leadership for formulation and process development, scale-up, technology transfer, process characterization, process validation/PPQ, continued process verification, and manufacturing lifecycle management, as applicable.
• Oversee clinical and commercial manufacturing strategy and execution in coordination with external manufacturers and internal stakeholders; ensure appropriate Technical Operations support for critical manufacturing campaigns, product launches, and supply requirements.
• Provide senior technical review and oversight of manufacturing and process documentation, process performance, significant vendor changes, investigations, annual/product reviews, and significant deviations, out-of-specification or atypical results, and complex manufacturing problems; ensure robust technical investigation, root-cause analysis, effective corrective and preventive actions, continued process control, and reliable manufacturing in partnership with Quality Assurance.
• Lead technical assessments of significant manufacturing, process, component, and supplier changes and coordinate evaluation of quality, regulatory, supply, financial, and business impacts with appropriate functional stakeholders.
• Establish and review manufacturing, supply, and external partner performance metrics and KPIs, including service, quality, on-time delivery, right-first-time, cost, capacity, and other appropriate measures; drive lifecycle improvements, operational excellence, capacity planning, cost improvement, and risk-reduction initiatives across the external network.
• Lead external partner business and technical governance, including selection and strategic development of CMOs, CDMOs, suppliers, and other critical partners; establish performance expectations and governance mechanisms, oversee business reviews, scopes of work, proposals, change orders, contract and supply agreement support, and escalation of commercial or operational issues; and develop business continuity, capacity, and second-source strategies for critical manufacturing capabilities and materials.
• Represent Technical Operations on cross-functional program and leadership teams; communicate manufacturing strategy, program status, significant risks, financial implications, and recommendations to senior management and key stakeholders.
• Partner with Regulatory Affairs on CMC strategy, regulatory submissions, post-approval changes, and health authority responses; ensure manufacturing plans and technical decisions are aligned with regulatory commitments.
• Lead Technical Operations business planning and continuous improvement initiatives, including departmental budget development with Finance/FP&A, contract lifecycle management, operational process standardization, and long-range manufacturing planning.
• Provide leadership and governance for commercial supply operations managed within Technical Operations, including 3PL and distribution partner performance, inventory and supply continuity, shipping/returns interfaces, and support of product launches and new markets.
• Oversee the commercial serialization program, including serialized packaging operations, EPCIS data exchange with trading partners and service providers, and compliance with applicable Drug Supply Chain Security Act (DSCSA) requirements; ensure issues are appropriately escalated and resolved cross-functionally.
• Provide leadership and oversight for clinical supply operations, including clinical material planning, packaging, labeling, distribution, inventory/expiry management, and coordination of Interactive Response Technology/Interactive Web Response System (IRT/IWRS) activities with Clinical Operations and external vendors.

 KNOWLEDGE, SKILLS, AND ABILITIES:

• Broad and deep knowledge of cGMP, pharmaceutical manufacturing, quality systems, formulation and process development, scale-up, technology transfer, process validation, lifecycle management, and applicable CMC regulatory expectations, with the technical credibility to critically challenge external partner data, conclusions, and recommendations.
• Demonstrated leadership of outsourced manufacturing relationships, complex cross-functional programs, and teams, including governance, performance management, contract/scope management, budgeting, executive-level escalation, influence without direct authority, and accountability of external partners for performance and commitments.
• Strong strategic, analytical, and problem-solving capability, with demonstrated ability to evaluate complex technical and business issues, balance risk, cost, supply continuity, and regulatory considerations, and make sound recommendations.
• Excellent written, verbal, negotiation, and presentation skills with the ability to influence across functions and organizational levels and communicate effectively with senior management and external partners.
• Strong business and financial acumen, including the ability to translate budgets, forecasts, manufacturing costs, contract terms, and operational metrics into business decisions and actions.
• Experience establishing scalable Technical Operations processes and systems; proficiency with Microsoft Office and relevant project, reporting, or data-management tools.
• Demonstrated knowledge of commercial and clinical supply operations within an outsourced model, including 3PL management, serialization/EPCIS and DSCSA compliance, and clinical supply/IRT/IWRS processes.
• Must be able to travel domestically and internationally up to approximately 25% to support external manufacturing partners, governance meetings, and key manufacturing activities.

 EDUCATION AND EXPERIENCE:

• Bachelor’s degree in pharmaceutical sciences, chemistry, chemical engineering, engineering, or related scientific/technical discipline; an advanced degree (MS, PhD, or MBA) is preferred. An acceptable combination of education and relevant experience will also be considered.
• Minimum of 10+ years of relevant pharmaceutical/biotechnology experience in Technical Operations, manufacturing, process development, CMC, or related functions, with demonstrated leadership of complex programs and external manufacturing relationships.
• Significant experience managing external CMOs/CDMOs in an outsourced operating model and supporting GMP clinical and commercial manufacturing is required.
• Experience with drug-device combination products, nasal/inhalation products, sterile manufacturing, process validation/PPQ, commercial product launch, and lifecycle management is strongly preferred.
• Experience supporting CMC regulatory strategy and submissions, major investigations and change controls, vendor/supply agreements, budget planning, and business continuity is preferred. Prior people-management or functional leadership experience is strongly preferred.
• Experience overseeing commercial distribution and 3PL partners, serialization/EPCIS and DSCSA compliance, and clinical supply operations including IRT/IWRS is strongly preferred; experience across multiple of these areas is preferred.