Associate Director, Process & Analytical Development

Lonza•Walkersville, MD

2d•$155,700 - $181,650•Remote

About The Position

The Associate Director, Process & Analytical Development (ADPD) provides strategic and operational leadership for analytical development, process development, and project-specific manufacturing activities within the ADPD organization. This role is accountable for ensuring the organization consistently delivers services and products safely, compliantly, on time, in full, and within budget while supporting ADS business objectives and long-term growth strategies. This position will initially operate remotely and transition to the future U.S. ADPD center of gravity as the organization continues to expand.

Requirements

Master’s degree in engineering, Life Sciences, Pharmaceutical Sciences, Chemistry, Biochemistry, or a related scientific discipline.
Minimum of 10 years of progressive leadership experience in pharmaceutical, biotechnology, process development, analytical development, or manufacturing operations.
Deep understanding of small molecule and bioconjugate technologies.
Significant experience within GMP-regulated pharmaceutical or biotechnology environments.
Proven leadership experience supporting facility startups, technology transfers, validation programs, operational readiness initiatives, or large-scale capital projects.
Strong knowledge of pharmaceutical manufacturing operations, GMP requirements, process development, analytical development, and commercialization activities.
Experience supporting greenfield and brownfield facility expansion projects and cross-functional project governance.
Demonstrated expertise in small molecule drug substance manufacturing processes and technologies.
Proven ability to influence cross-functional stakeholders including Engineering, Quality, Manufacturing, MSAT, Automation, EH&S, Finance, and Human Resources.
Strong strategic and practical problem-solving capabilities with the ability to translate business requirements into operational solutions.
Excellent executive communication and presentation skills, with experience reporting risks, operational readiness, and business performance to senior leadership.
Demonstrated success building teams, developing organizational capability, and preparing organizations for operational growth.
Knowledge of Lean Manufacturing, Six Sigma methodologies, digital systems, automation technologies, and data integrity principles.
Ability to thrive in a dynamic environment and effectively manage ambiguity, evolving priorities, and multiple stakeholder groups.
Strong leadership presence with a track record of delivering results through collaboration, innovation, and accountability.

Responsibilities

Lead, coach, and develop a high-performing Process & Analytical Development team, fostering a culture of accountability, collaboration, safety, continuous improvement, and operational readiness.
Define the strategic direction of the ADPD organization through long-range planning, portfolio prioritization, resource allocation, and performance management.
Drive organizational readiness and capability development to support future manufacturing operations and business growth.
Serve as a key contributor to the Sales & Operations Planning (S&OP) process, ensuring capabilities, capacity, and organizational structures align with customer demand and business objectives.
Ensure the successful execution of all development and manufacturing activities while meeting safety, quality, compliance, and business requirements.
Maintain ownership of operational budgets and resources to ensure efficient and effective organizational performance.
Drive Lean maturity and continuous improvement initiatives across the organization, establishing a culture focused on operational excellence and performance.
Lead the execution of strategic initiatives that support business objectives and organizational growth within the ADPD function.
Partner closely with R&D and technical organizations to support the deployment of new technologies and innovative development approaches.
Serve as a subject matter expert during product acquisition, technology transfer, and process development activities.
Support facility startup, operational readiness, validation, and manufacturing scale-up initiatives.
Collaborate with Engineering, Manufacturing, Quality, MSAT, Automation, EH&S, Finance, and HR to ensure successful project execution and organizational alignment.
Establish strong governance and communication practices that enable effective decision-making and risk management.
Build organizational capability and succession plans to support future operational requirements.
Drive adoption of digital tools, automation solutions, and data-driven decision-making practices.