Associate Director (Manu) Houston, TXThe actual location of this job is in Houston, Texas, USA. Relocation assistance is available for eligible candidates and their families, if needed.This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.This role is primarily based on site. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards. We offer flexibility to work remotely for no more than 20% of your time. Requests are considered on a case‑by‑case basis, in line with business needs.This is an office‑first role. Working together in person supports close, real‑time collaboration and team alignment, enabling us to deliver our best work. You will work primarily in the office, with the flexibility to work remotely for 20% of your time (one day per week).
What you will do:- 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.
What we are looking for:- 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.
