THE OPPORTUNITYThe Director / Senior Director, Technical Operations will provide strategic leadership for ARS' external manufacturing and Technical Operations activities supporting the continued development, lifecycle management, and commercial supply of neffy™. The successful candidate will combine strong technical, business, and operational leadership with cross-functional influence and CMO management expertise to drive manufacturing excellence, scalable operations, and reliable product supply.
This role is accountable for manufacturing strategy, CMO performance, process and technology lifecycle management, resolution of major technical issues, and execution of key Technical Operations initiatives across the ARS outsourced manufacturing network. Working closely with internal stakeholders and external partners, the position leads complex cross-functional programs, oversees partner performance and agreements, manages departmental planning and budgets, and ensures technical, supply, regulatory, and business risks are appropriately identified, assessed, and escalated.
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.
At ARS, we are proud to offer a highly competitive compensation & benefits package.
The full-time salary range for this posted position is$225,000 to $275,000 and may be eligible for a discretionary annual performance bonus. Actual pay rates are determined by considering multiple factors including qualifications, relevance of experience, education & credentials, subject matter expertise, and other job-related factors permitted by law.
This position is also eligible for Equity, 401k matching, and our excellent benefits package including 100% employer paid Medical, Dental & Vision for employees. View the full package here: ARS Careers Page
The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.
