Director, Manufacturing

🕒 il y a 2 mois

🦀 Maryland – Distant

🦀 Maryland – Remote

💵 $198 900 - $232 050 / an

⏰ Temps Plein

🔴 Expert

👔 Directeur

👻 Score fantôme 7%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Lonza

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1897

🧬 Biotechnologie

💊 Pharmaceutique

🏭 Fabrication

💰 €444 795 339 Post-IPO Debt - Lonza en 2023-11

Biotechnology • Pharmaceuticals • Manufacturing

Lonza est une organisation mondiale de développement et fabrication sous contrat (CDMO) et une entreprise de sciences de la vie basée en Suisse. Elle propose une gamme intégrée de services complets allant du développement et de la fabrication de médicaments biologiques et de petites molécules - y compris le développement de lignées cellulaires, le développement de procédés et d'analyses, la formulation et le conditionnement primaire, la fabrication de substances actives et de produits finis, ainsi que le soutien réglementaire/CMC. Les capacités de Lonza englobent la synthèse avancée et les API (y compris les HPAPI), la bioconjugaison et les ADC, des modalités spécialisées telles que les thérapies cellulaires et géniques, l'ARNm/LNP, les procédés microbiens, ainsi que les produits de capsules et d'ingrédients de santé. Fondée en Suisse en 1897, Lonza se décrit comme un pionnier et un leader mondial dans l'industrie CDMO et opère avec environ 20,000 collaborateurs sur cinq continents pour soutenir les clients pharmaceutiques et biotechnologiques.

Description

• 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.

🎯 Exigences

• 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.

🏖️ Avantages

• 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).