Director, Operations

🕒 il y a 3 jours

🦀 Maryland – Distant

🦀 Maryland – Remote

💵 $198 900 - $232 050 / an

⏰ Temps Plein

🔴 Expert

⚙️ Opérations

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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

• 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

🎯 Exigences

• 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

🏖️ Avantages

• 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)