Director, MSAT

🕒 il y a 1 mois

🦀 Maryland – Distant

🦀 Maryland – Remote

💵 $205 200 - $239 400 / an

⏰ Temps Plein

🔴 Expert

👔 Directeur

👻 Score fantôme 6%

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

• Lead the MSAT workstream for an assigned U.S. growth investment project, ensuring successful process implementation and operational readiness for small molecule manufacturing operations • Develop and execute the process robustness and readiness roadmap, coordinating internal and external stakeholders throughout design, construction, commissioning, qualification, and start-up activities • Provide leadership for process-related commissioning, qualification, validation readiness, start-up activities, and transfer to commercial operations • Own process lifecycle management activities, including process introduction, technology transfer, validation strategy, process monitoring, continuous improvement, and regulatory support • Partner with Engineering, Manufacturing, Quality, Automation, and EHS teams to ensure process requirements are incorporated into facility, equipment, and automation design decisions • Drive technology transfer, process scale-up, and product introduction activities supporting clinical and commercial small molecule manufacturing programs • Identify, assess, and mitigate technical, operational, and project-related risks while ensuring long-term process reliability, compliance, and operational excellence • Build, develop, and lead a high-performing MSAT organization while providing strategic updates, readiness assessments, and recommendations to senior leadership and project governance teams

🎯 Exigences

• Master’s degree in engineering, Chemistry, Pharmaceutical Sciences, Life Sciences, or a related discipline preferred; Bachelor's degree with significant relevant experience will also be considered • 12+ years of experience in pharmaceutical or API manufacturing, including leadership experience within MSAT, Technical Operations, Process Engineering, or Manufacturing Operations • Demonstrated experience supporting or leading small molecule drug substance manufacturing processes, including process scale-up, technology transfer, process validation, commercial manufacturing support, and lifecycle management and process robustness • Proven experience supporting major capital investment projects, facility start-ups, manufacturing expansions, or large-scale operational growth initiatives • Strong knowledge of GMP manufacturing operations, regulatory requirements, commissioning, qualification, validation, process performance monitoring, technology transfer, and inspection readiness within a small molecule manufacturing environment • Experience leading cross-functional teams and influencing stakeholders across Engineering, Manufacturing, Quality, Automation, Analytical Development, Supply Chain, EHS, Finance, and Project Management organizations • Experience leading technology transfer, process scale-up, and commercialization within a multi-product API manufacturing or CDMO environment, including cross-site product transfers, is preferred. • Demonstrated success building and developing high-performing technical teams while driving operational excellence, continuous improvement, and organizational readiness • Excellent communication, strategic planning, and risk management skills, with experience presenting to executive leadership, governance committees, customers, and external 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 to EMEA and NA at approximately 25-30% of the time to meet business objectives.

🏖️ 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).