Director, Operations

🕒 Agosto 4

🦀 Maryland – Remoto

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💵 $198.900 - $232.050 / ano

⏰ Tempo Integral

🔴 Especialista

⚙️ Operações

👻 Score fantasma 8%

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🗣️🇺🇸🇬🇧 Inglês obrigatório

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Logo of Lonza

Lonza

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

• Develop and execute the operational readiness strategy for an assigned U.S. growth investment project supporting small molecule drug substance manufacturing • Lead operational readiness activities, including operating model development, staffing plans, training strategy, and start-up preparation • Define the future manufacturing organization, including workforce planning, organizational structure, shift models, governance processes, and operational ownership • Represent Operations during facility and process design to ensure manufacturing requirements are incorporated into equipment, automation, process flow, and facility decisions • Partner with Engineering, MSAT, Quality, Automation, and EHS teams throughout project execution • Ensure manufacturing readiness and GMP compliance through commissioning, qualification, validation, inspection preparedness, and operational excellence activities • Lead readiness activities for technology transfer, process implementation, and product introduction for small molecule manufacturing programs • Identify, assess, and mitigate operational, technical, and project risks • Build and develop a high-performing operations organization • Provide readiness updates, risk assessments, and strategic recommendations to senior leadership and project governance teams

🎯 Requisitos

• Bachelor’s degree in engineering, Chemistry, Pharmaceutical Sciences, Life Sciences, or a related discipline • 12+ years of leadership experience in pharmaceutical or API manufacturing, including Operations, Manufacturing, Technical Operations, or related functions • Experience supporting or leading small molecule drug substance manufacturing operations, preferably in API, HPAPI, or complex chemical manufacturing environments • Experience with commercial manufacturing, technology transfer, validation, and operational readiness • Experience supporting major capital projects, facility expansions, greenfield or brownfield investments, manufacturing start-ups, or large-scale growth initiatives • Strong knowledge of GMP manufacturing operations, regulatory expectations, process validation, commissioning, qualification, inspection readiness, and process safety principles within API or chemical manufacturing • Experience leading cross-functional teams and influencing stakeholders across Engineering, Manufacturing, Quality, MSAT, Automation, EHS, HR, Finance, and Project Management functions • Demonstrated success building organizations, developing talent, and establishing sustainable operating models within complex manufacturing environments • Strong communication, strategic planning, problem-solving, and change management skills • 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 • Experience with HPAPI, complex chemical synthesis, chemical process manufacturing, or containment-intensive manufacturing environments preferred • Advanced degree preferred

🏖️ Benefícios

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

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