Director, Process & Analytical Development

Lonza

Lonza life-sciences leader directing process, analytical, and project-specific manufacturing development. Building U.S.

Posted 8/17/2026full-timeWalkersville • Maryland • 🇺🇸 United StatesLead💰 $196,700 - $232,650 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive leadership in Process Development, Analytical Development, and Technical Operations within GMP-regulated environments, with a strong focus on operational excellence, strategic planning, and budget management. Capable of driving transformation initiatives and collaborating across multiple functions to achieve business growth and compliance.

Highest-signal resume keywords

Leadership Experience in Pharmaceutical ManufacturingProcess Development and Analytical DevelopmentUnderstanding of cGMP RequirementsLean Manufacturing and Six Sigma ExpertiseStrategic Planning and Budget Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Process DevelopmentAnalytical DevelopmentTechnical OperationsSmall Molecule Drug Substance ManufacturingTechnology TransferValidationOperational ReadinessCommercialization ActivitiesPortfolio ManagementResource Allocation

Soft Skills

LeadershipCommunicationProblem-SolvingDecision-MakingCollaboration

Tools & Technologies

Lean ManufacturingSix SigmaDigital SystemsData Integrity PrinciplesAutomation

Industry Keywords

PharmaceuticalBiotechnologyCDMOGMP-Regulated OrganizationsFacility StartupCapital InvestmentSales & Operations PlanningOperational ExcellenceTransformation ProgramsCompliance

About the role

Key responsibilities & impact

Provide overall leadership for analytical development, process development, and project-specific manufacturing activities within the ADS US organization
Ensure the ADPD organization delivers services and products safely, compliantly, on time, in full, and within budget
Lead, coach, and develop a high-performing ADPD organization
Define and execute strategic direction through long-term planning, portfolio management, resource allocation, organizational design, and performance management
Establish capabilities, infrastructure, and talent for future manufacturing operations and business growth
Contribute to the Sales & Operations Planning (S&OP) process
Oversee development and project-specific manufacturing activities against Safety, Quality, Compliance, Delivery, and Cost expectations
Own organizational budgets, resource planning, and operational performance
Drive Lean maturity, Operational Excellence, and continuous improvement
Lead strategic initiatives and transformation programs
Partner with R&D, Manufacturing, MSAT, Engineering, Quality, Automation, Supply Chain, and Commercial teams
Evaluate, acquire, and implement new technologies
Establish governance processes, performance metrics, and decision-making frameworks
Support site startup, facility expansion, validation, and capital investment initiatives

Requirements

What you’ll need

Master’s degree in engineering, Life Sciences, Chemistry, Pharmaceutical Sciences, or a related field required
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 in 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
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 collaborate across Engineering, Quality, MSAT, Automation, Manufacturing, EHS, HR, Finance, and Commercial functions
Ability to translate business requirements into practical, scalable operational solutions
Strong executive presence and ability to communicate readiness, risks, performance, and recommendations to senior leadership
Experience building organizations, developing talent, and preparing teams for future needs
Understanding of Lean Manufacturing, Six Sigma, Operational Excellence, automation, digital systems, and data integrity principles
Capability in portfolio management, strategic planning, budget ownership, and resource allocation
Ability to navigate ambiguity, manage competing priorities, and lead in a fast-paced environment
Strong leadership, communication, problem-solving, and decision-making 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 approximately 25–30% of the time

Benefits

Comp & perks

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)