Director, Process & Analytical Development

Lonza•Walkersville, MD

2d•$196,700 - $232,650•Remote

About The Position

The Director, Process & Analytical Development (ADPD) provides overall leadership for all analytical development, process development, and project-specific manufacturing activities within the ADS US organization. The incumbent is accountable for ensuring the ADPD organization consistently delivers services and products safely, compliantly, on time, in full, and within budget while aligning with ADS business objectives and strategic growth priorities. This position will initially operate remotely and transition to the future center of gravity for ADPD in the United States as the organization continues to expand.

Requirements

Master’s degree in engineering, Life Sciences, Chemistry, Pharmaceutical Sciences, or a related field required; PhD preferred.
15+ years of progressive leadership experience within pharmaceutical, biotechnology, CDMO, or related life sciences environments.
Deep understanding of small molecule and bioconjugate technologies.
Extensive leadership experience within Process Development, Analytical Development, Technical Operations, Manufacturing, or related GMP-regulated organizations.
Strong understanding of pharmaceutical manufacturing operations, cGMP requirements, technology transfer, validation, operational readiness, and commercialization activities.
Demonstrated experience supporting facility startup, expansion projects, greenfield or brownfield investments, and large-scale capital programs.
Proven success leading organizations through growth, transformation, and operational scale-up initiatives.
Strong technical knowledge and experience in small molecule drug substance manufacturing.
Ability to influence and collaborate across Engineering, Quality, MSAT, Automation, Manufacturing, EHS, HR, Finance, and Commercial functions without relying solely on direct authority.
Demonstrated ability to translate business requirements into practical, scalable operational solutions.
Strong executive presence with the ability to communicate operational readiness, risks, business performance, and strategic recommendations to senior leadership and governance bodies.
Experience building organizations, developing talent, and preparing teams for future operational and business needs.
Strong understanding of Lean Manufacturing, Six Sigma, Operational Excellence, automation, digital systems, and data integrity principles.
Demonstrated capability in portfolio management, strategic planning, budget ownership, and resource allocation.
Ability to effectively navigate ambiguity, manage competing priorities, and lead within a fast-paced environment with multiple stakeholders.
Strong leadership, communication, problem-solving, and decision-making skills with a track record of delivering sustainable business results.
Ability and willingness to transition to an East Coast or Midwest U.S. site location as project needs evolve.

Nice To Haves

PhD preferred.

Responsibilities

Lead, coach, and develop a high-performing ADPD organization, fostering a culture of ownership, collaboration, accountability, safety, innovation, and continuous improvement.
Define and execute the strategic direction of the ADPD organization through long-term planning, portfolio management, resource allocation, organizational design, and performance management.
Establish the capabilities, infrastructure, and talent required to support future manufacturing operations, business growth, and operational readiness.
Serve as a key contributor to the Sales & Operations Planning (S&OP) process, ensuring development capabilities, capacity, and organizational structures are aligned with business objectives and customer demand.
Provide leadership and oversight for all development and project-specific manufacturing activities, ensuring execution meets Safety, Quality, Compliance, Delivery, and Cost expectations.
Maintain ownership and accountability for organizational budgets, resource planning, and operational performance.
Drive Lean maturity across the organization, establishing a culture of Operational Excellence and continuous improvement that supports sustainable business performance.
Lead strategic initiatives and transformation programs that advance the ADPD organization's capabilities, efficiency, and effectiveness.
Partner closely with R&D, Manufacturing, MSAT, Engineering, Quality, Automation, Supply Chain, and Commercial teams to ensure successful technology transfer, operational readiness, and commercialization execution.
Act as a key stakeholder in the evaluation, acquisition, and implementation of new technologies, ensuring the organization maintains state-of-the-art scientific and technical capabilities.
Establish governance processes, performance metrics, and decision-making frameworks that support business objectives and organizational growth.
Support site startup, facility expansion, validation, and capital investment initiatives as required to meet future business needs.