Director, Operations

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🔥 1 minute ago

🦀 Maryland – Remote

🦀 Maryland – Remote

💵 $198.9k - $232.1k / year

⏰ Full Time

🔴 Lead

⚙️ Operations

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Lonza

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1897

🧬 Biotechnology

💊 Pharmaceuticals

🏭 Manufacturing

💰 $444.8M Post-IPO Debt - Lonza on 2023-11

Biotechnology • Pharmaceuticals • Manufacturing

Lonza is a Swiss-based, global contract development and manufacturing organization (CDMO) and life sciences company. It provides integrated end-to-end offerings across biologics and small-molecule drug development and manufacturing — including cell line development, process and analytical development, formulation and primary packaging, drug substance and drug product manufacturing, and regulatory/CMC support. Lonza's capabilities span advanced synthesis and APIs (including HPAPIs), bioconjugation and ADCs, specialized modalities such as cell & gene therapies, mRNA/LNP, microbial processes, and capsule and health-ingredient products. Founded in Switzerland in 1897, Lonza describes itself as a pioneer and world leader in the CDMO industry and operates with ~20,000 colleagues across five continents to support pharmaceutical and biotech customers.

📋 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

🎯 Requirements

• 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

🏖️ Benefits

• 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)