Associate Director, Manufacturing

Lonza • Houston, TX

4d • Hybrid

About The Position

The Associate Director (Manu) in Houston, TX, is a fully site-based role focused on leading end-to-end operational readiness for viral vector drug product and sterile fill/finish operations within a cGMP manufacturing environment. This role involves owning the governance and execution oversight for drug product-related technology transfers, new product introductions (NPI), and major operational initiatives. The position requires establishing and standardizing a site-wide drug product and fill/finish platform, developing and mentoring a specialized team, and shaping long-term strategic planning for drug product and fill/finish operations. The Associate Director will partner with Quality, MSAT, and Validation functions to ensure robust deviation management and inspection readiness, drive the proactive identification and resolution of operational constraints, and engage early with clients and commercial teams to define executable drug product strategies. Collaboration with global drug product sites across the network is essential for aligning platform standards and knowledge sharing. The role also involves representing the drug product/fill-finish operation in governance forums to ensure alignment on strategy and performance. Lonza values diversity and is committed to creating an inclusive environment for all employees, where everyone's ideas have the potential to improve millions of lives.

Requirements

• Demonstrated expertise in drug product and sterile fill/finish operations within a multi-product GMP environment, including capacity modeling, readiness planning.
• Proven ability to translate client program requirements and commercial pipeline demand into executable drug product operational strategies, aligning scope, timelines, facility fit, and risk mitigation plans with site and network capabilities.
• Experience establishing and optimizing drug product/fill-finish platform governance, including standardized readiness frameworks, stage-gate processes, and cross-functional accountability systems that support scalable, repeatable execution.
• Strong analytical capability in manufacturing readiness assessment, including critical path mapping, DP-material/component readiness evaluation, and risk-based milestone management for complex DP technology transfers and new product introductions.
• Deep understanding of sterile manufacturing, fill/finish unit operations, and viral vector drug product considerations, with the ability to identify process–facility alignment risks and define mitigation strategies to ensure compliant and successful operations.
• Demonstrated ability to influence senior stakeholders and lead cross-functional decision-making in resource-constrained, high-mix CDMO or multi-program environments, balancing business continuity, compliance, and client commitments.
• Proven track record leading complex, cross-functional initiatives, managing multiple concurrent DP workstreams (NPI, tech transfer, readiness, CAPA closure, equipment qualification) in fast-paced, highly regulated manufacturing settings.
• Strong strategic and analytical thinking capability, using quantitative and qualitative insight (capacity modeling, scenario planning, throughput analysis) to drive long-term DP platform evolution and operational excellence.
• Demonstrated leadership presence, both formal and informal, with the ability to build high-performing teams, elevate technical capabilities, and influence cross-functional partners across Manufacturing, QA, MSAT, and Commercial.
• Exceptional communication and interpersonal skills, capable of translating complex DP, aseptic, and operational concepts into clear messaging tailored for stakeholders, clients, and global teams.
• Proactive, adaptive, and solutions-oriented mindset, thriving in ambiguity, maintaining strong ownership, and consistently executing with a customer-focused, enterprise-first perspective.

Responsibilities

• Lead end-to-end operational readiness for viral vector drug product and sterile fill/finish operations within a cGMP manufacturing environment, ensuring facility, process, and team preparedness to deliver clinical and commercial batches safely, compliantly, and on schedule.
• Own governance and execution oversight for drug product-related technology transfers, new product introductions (NPI), and major operational initiatives, integrating Manufacturing, MSAT, Quality, Supply Chain, and Program Management to ensure structured risk management, milestone control, and scalable fill/finish delivery models.
• Establish, standardize, and sustain a site-wide drug product and fill/finish platform, including harmonized procedures, readiness frameworks, and performance management systems that drive transparency, cross-functional accountability, and consistent execution across all DP programs.
• Develop and mentor a team specializing in drug product and fill/finish operations, strengthening technical depth in aseptic processing, decision-making capability, and cross-functional influence while building organizational capability and succession strength.
• Shape long-term DP/fill-finish strategic planning by translating program and pipeline demand into capacity scenarios, resource models, platform evolution needs, and operational roadmaps aligned with site and network growth strategies.
• Partner with Quality, MSAT, and Validation functions to ensure robust deviation management, change control lifecycle governance, inspection readiness, and a quality-focused culture that supports continuous improvement in DP and Fill/Finish operations.
• Drive proactive identification and resolution of complex drug product operational constraints, including sterile suite utilization, material and component readiness, fill-finish sequencing, equipment qualification, and batch scheduling to safeguard delivery commitments and business continuity.
• Engage early with clients and internal commercial teams to define executable drug product strategies, operational configurations, and risk mitigation plans that align manufacturing capability with program expectations and business development objectives.
• Collaborate with global drug product sites across the network, aligning platform standards, enabling bi-directional knowledge sharing, and ensuring consistent operating models that strengthen site DP/fill-finish capability.
• Represent the drug product/fill-finish operation in site and global governance forums, ensuring alignment on readiness strategy, operational performance, and long-term positioning of the drug product platform within the broader manufacturing network.

Benefits

• Relocation assistance is available for eligible candidates and their families, if needed.
• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• A variety of benefits dependent on role and location.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: No Education Listed