Director, Manufacturing

🕒 vor 12 Tagen

🦀 Maryland – Remote

🦀 Maryland – Remote

💵 $198.900 - $232.050 / Jahr

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Lonza

WebsiteLinkedInAlle Stellen

10.000+ Mitarbeiter

Gegründet 1897

🧬 Biotechnologie

💊 Pharmazie

🏭 Fertigung

💰 €444.795.339 Post-IPO Debt - Lonza im 2023-11

Biotechnology • Pharmaceuticals • Manufacturing

Lonza ist ein weltweit tätiges Schweizer Vertragsentwicklungs- und Produktionsunternehmen (CDMO) sowie ein Unternehmen der Life Sciences. Es bietet integrierte End-to-End-Lösungen für die Entwicklung und Herstellung von biologischen und chemischen Wirkstoffen an - einschließlich Zelllinienentwicklung, Prozess- und Analytikentwicklung, Formulierung und Primärverpackung, Wirkstoff- und Arzneimittelproduktion sowie regulatorische/CMC-Unterstützung. Lonzas Kompetenzen umfassen fortgeschrittene Synthesen und APIs (einschließlich HPAPIs), Biokonjugation und ADCs, spezialisierte Modalitäten wie Zell- und Gentherapien, mRNA/LNP, mikrobielle Prozesse sowie Kapseln und Gesundheitsprodukte. Gegründet 1897 in der Schweiz, bezeichnet sich Lonza als Pionier und Weltmarktführer in der CDMO-Branche und arbeitet mit etwa 20. 000 Kollegen auf fünf Kontinenten, um pharmazeutische und biotechnologische Kunden zu unterstützen.

Beschreibung

• The Director, Manufacturing – US Growth Investment Projects is responsible for developing and executing the operational readiness strategy for an assigned U.S. growth investment project supporting bioconjugate drug substance manufacturing. • This role serves as the primary Operations representative throughout facility design, construction, commissioning, qualification, validation, start-up, and operational handover, ensuring the new facility is GMP-compliant, inspection-ready, and capable of supporting clinical and commercial manufacturing from day one. • Working closely with the End-to-End Program Lead, Global Engineering, Quality, MSAT, Manufacturing, Automation, EHS, HR, and Finance, the Director will ensure operational requirements are embedded throughout the project lifecycle while building the future manufacturing organization and operating model. • Lead operational readiness activities for an assigned U.S. growth investment project, ensuring successful start-up and transition into routine GMP manufacturing operations. • Develop and execute the operations readiness roadmap, including organizational design, workforce planning, training strategy, process readiness, validation support, and operational handover. • Define the future manufacturing organization, including staffing plans, shift structures, organizational interfaces, governance models, and operational ownership. • Serve as the primary Operations representative for facility and process design reviews, ensuring manufacturing requirements are incorporated into equipment, automation, process flow, and facility decisions. • Partner with Engineering, Quality, MSAT, Automation, and EHS to ensure operational requirements are appropriately integrated throughout project execution. • Establish processes and systems that ensure GMP compliance, operational excellence, inspection readiness, and long-term manufacturing reliability. • Lead operational planning and readiness activities associated with technology transfers, customer onboarding, process implementation, and commercial launch activities. • Identify, assess, and mitigate operational, technical, organizational, and project risks associated with staffing, training, equipment readiness, start-up execution, and manufacturing performance. • Build, develop, and lead a high-performing manufacturing organization while fostering a culture of accountability, safety, quality, and continuous improvement. • Provide operational readiness updates, risk assessments, mitigation strategies, and recommendations to project governance teams and senior leadership.

🎯 Anforderungen

• Master’s degree in engineering, Biotechnology, Life Sciences, Pharmaceutical Sciences, or a related discipline preferred; bachelor’s degree with significant relevant experience will also be considered. • 12+ years of leadership experience within pharmaceutical, biotechnology, biologics, or bioconjugate manufacturing environments. • Demonstrated experience leading manufacturing operations within a CDMO environment, including customer-facing interactions, technology transfers, operational planning, and support of multiple client programs. • Significant experience supporting or leading bioconjugate drug substance manufacturing operations, including scale-up, validation, technology transfer, start-up, and commercial manufacturing. • Proven experience supporting major capital projects, facility expansions, greenfield or brownfield investments, and manufacturing facility start-ups. • Strong knowledge of GMP manufacturing operations, regulatory requirements, process validation, commissioning, qualification, operational readiness, and inspection preparedness. • Demonstrated success leading large, cross-functional teams and influencing stakeholders across Operations, MSAT, Quality, Engineering, Automation, EHS, Supply Chain, HR, Finance, and Project Management. • Experience building manufacturing organizations, developing talent, and preparing teams for successful operational launch and long-term site performance. • Strong understanding of customer requirements within a CDMO business model, including program execution, relationship management, and delivery against customer commitments. • Strategic thinker with the ability to translate business objectives into scalable operational solutions. • Excellent communication and executive presentation skills, with experience presenting to senior leaders, governance bodies, customers, and external stakeholders. • Demonstrated capability to identify and mitigate operational, technical, compliance, and project execution risks. • Knowledge of Lean Manufacturing, Six Sigma, automation systems, digital manufacturing platforms, and data integrity principles preferred. • Ability to operate effectively in a fast-paced project environment with evolving priorities and multiple stakeholders. • Ability and willingness to transition to an East Coast or Midwest U.S. site location as project needs evolve. • Willingness and ability to travel domestically and internationally up to approximately 25–30% of the time.

🏖️ Vorteile

• Performance-related bonus. • Medical, dental and vision insurance. • 401(k) matching plan. • Life insurance, as well as short-term and long-term disability insurance. • Employee assistance programs. • Paid time off (PTO).