THE OPPORTUNITY

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Manage cross-functional Technical Operations projects and day-to-day technical and operational interactions with assigned external partners, including scope, timelines, deliverables, responsibilities, budgets, risks, key milestones, project meetings, action tracking, scopes of work, proposals, change orders, and CMO/vendor performance metrics and KPIs (e.g., service, quality, delivery, capacity, and right-first-time).
• Serve as a Technical Operations point of contact for assigned external manufacturing partners and work closely with CMOs and internal stakeholders to ensure execution against agreed project plans and supply requirements.
• Provide technical oversight of formulation and process development, scale-up, technology transfer, process characterization, process validation/PPQ, and continued process verification activities, as applicable.
• Plan and support clinical and commercial manufacturing campaigns in coordination with CMOs, Supply Chain, Quality Assurance, and other internal functions; provide on-site/person-in-plant support for key manufacturing activities as needed.
• Review manufacturing and process documentation, including master and executed batch records, protocols, reports, process performance data, vendor change controls, investigations, and annual/product reviews, for technical accuracy and process performance.
• Lead or support technical assessment and resolution of manufacturing deviations, out-of-specification or atypical results, and other process issues; contribute to root-cause analysis and appropriate corrective and preventive actions in partnership with Quality Assurance.
• Assess proposed manufacturing and process changes for technical impact and support cross-functional evaluation of quality, supply, and regulatory implications.
• Monitor and trend manufacturing and process performance data to identify emerging risks, process drift, and opportunities for continuous improvement and operational excellence.
• Support vendor selection, onboarding, and qualification activities in collaboration with Quality Assurance, Supply Chain, Procurement, and other stakeholders.
• Communicate project status, technical risks, manufacturing issues, and recommend actions clearly to Technical Operations leadership and cross-functional stakeholders; escalate significant issues to appropriate decision-makers.
• Support preparation and review of CMC information for regulatory submissions and responses to health authority questions, as required.
• Support Technical Operations process improvement, business continuity, capacity planning, and other strategic operational initiatives as assigned.
• Support commercial supply operations managed within Technical Operations, including coordination with third-party logistics (3PL) providers, distribution partners, and external manufacturing/packaging partners to maintain reliable product supply.
• Support product serialization activities, including EPCIS data exchange and operational compliance with applicable Drug Supply Chain Security Act (DSCSA) requirements, working with packaging, distribution, Quality Assurance, and other partners as appropriate.
• Support clinical supply activities, including coordination with Clinical Operations and external vendors for clinical packaging, labeling, distribution, inventory/expiry management, and Interactive Response Technology/Interactive Web Response System (IRT/IWRS) activities, as applicable.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Strong working knowledge of current Good Manufacturing Practices (cGMP), pharmaceutical manufacturing operations, and applicable quality systems and regulatory expectations.
• Demonstrated technical understanding of formulation, manufacturing processes, scale-up, technology transfer, process validation, and process performance sufficient to critically evaluate CMO data and recommendations, work effectively in cross-functional technical teams, and hold external partners accountable to commitments.
• Strong project and vendor management skills, with demonstrated ability to manage multiple priorities, timelines, deliverables, and external partners in a fast-paced environment.
• Strong analytical and problem-solving skills, including the ability to evaluate complex manufacturing or process issues, develop recommendations, and communicate the rationale for action.
• Excellent written, verbal, and presentation skills with the ability to communicate effectively across functions and organizational levels, including senior management and external partners.
• Well-organized, detail-oriented, and able to identify and escalate risks while maintaining focus on execution and business priorities.
• Proficiency with Microsoft Office and project/reporting tools; experience with project management, continuous improvement, or operational excellence methodologies is a plus.
• Working knowledge of commercial and clinical supply operations relevant to Technical Operations, including 3PL interfaces, serialization/EPCIS and DSCSA requirements, and clinical IRT/IWRS processes; direct experience in one or more of these areas is preferred.
• Must be able to travel domestically and internationally up to approximately 20% to support external manufacturing partners and key project activities.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in pharmaceutical sciences, chemistry, chemical engineering, engineering, or a related scientific/technical discipline; an advanced degree is a plus. An acceptable combination of education and relevant experience will also be considered.
• Minimum of 5 years of relevant pharmaceutical/biotechnology experience in Technical Operations, manufacturing, process/formulation development, CMC, supply chain, or a related function.
• Experience working with external CMOs/CDMOs and supporting GMP clinical and/or commercial manufacturing is strongly preferred.
• Experience with drug-device combination products, nasal/inhalation products, sterile manufacturing, commercial product launch, or PPQ is preferred.
• Experience reviewing manufacturing batch records and process documentation and supporting technical investigations, change controls, and regulatory CMC activities is preferred.
• Experience supporting commercial distribution/3PL operations, serialization/EPCIS and DSCSA compliance, and/or clinical supply and IRT/IWRS activities is preferred.