Director, MSAT

🕒 6 dias atrás

🦀 Maryland – Remoto

🦀 Maryland – Remote

💵 $205.200 - $239.400 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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Lonza

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1897

🧬 Biotecnologia

💊 Farmacêutico

🏭 Manufatura

💰 $444.795.339 Post-IPO Debt - Lonza em 2023-11

Biotechnology • Pharmaceuticals • Manufacturing

A Lonza é uma organização global de desenvolvimento e fabricação contratada (CDMO) e uma empresa de ciências da vida sediada na Suíça. Ela oferece soluções integradas de ponta a ponta em desenvolvimento e fabricação de medicamentos biológicos e de pequenas moléculas — incluindo desenvolvimento de linhagens celulares, desenvolvimento e análise de processos, formulação e embalagem primária, fabricação de substâncias e produtos farmacêuticos, e suporte regulatório/CMC. As capacidades da Lonza abrangem síntese avançada e APIs (incluindo HPAPIs), bioconjugação e ADCs, modalidades especializadas como terapias celulares e gênicas, mRNA/LNP, processos microbianos, e produtos de cápsulas e ingredientes para saúde. Fundada na Suíça em 1897, a Lonza se descreve como pioneira e líder mundial na indústria de CDMO e opera com cerca de 20. 000 colaboradores em cinco continentes para apoiar clientes farmacêuticos e biotecnológicos.

Descrição

• 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

🎯 Requisitos

• 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.

🏖️ Benefícios

• 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).