Director, Process & Analytical Development

Lonza; United States; Remote; Confidential; Full time

Benefits offered by this job

Performance-related bonus

Medical, dental and vision insurance

401(k) matching plan

Life insurance, short-term and long‑tr

Employee assistance programs

Paid time off

Job summary

Lonza invites a seasoned Director of Process & Analytical Development to lead the ADPD organization in advancing analytical and process development for US operations. This role initially operates remotely with a transition to a future East Coast or Midwest center of gravity as the program evolves.

You will drive strategic planning, capability expansion, and cross-functional collaboration across R&D, Manufacturing, MSAT, and Quality to ensure safe, compliant, timely, and cost-effective execution,

Qualifications

• Master’s degree in engineering, life sciences, chemistry or pharma sciences is required; PhD preferred.
• 15+ years of progressive leadership experience in pharma/biotech/CDMO environments.
• Deep understanding of small molecule and bioconjugate technologies.
• Extensive leadership in Process Development, Analytical Development, Technical Operations, Manufacturing or GMP areas.
• Strong knowledge of pharmaceutical manufacturing operations, cGMP, tech transfer, validation and commercialization.
• Experience supporting facility startup, expansion projects and large-scale capital programs.
• Proven leadership in growing organizations and scaling operations.
• Ability to influence across Engineering, Quality, MSAT, Automation, Manufacturing, EHS, HR, Finance, and Commercial functions.
• Strong executive presence and ability to communicate with senior leadership.
• Experience building teams and preparing for future operational needs.
• Knowledge of Lean Manufacturing, Six Sigma, and data integrity principles.
• Willingness to transition to East Coast or Midwest sites as project needs evolve.
• Travel willingness to travel 25-30% to EMEA and NA.

Responsibilities

• Provide overall leadership for ADPD across analytical and process development and manufacturing activities.
• Lead the organization to ensure safe, compliant, on-time, full delivery within budget.
• Define and execute long-term strategic direction, portfolio management, and resource planning for ADPD.
• Establish capabilities, infrastructure, and talent to support future manufacturing and growth.
• Align development capabilities with S&OP processes and customer demand.
• Oversee development and project-related manufacturing with safety, quality, compliance and cost in mind.
• Own budgets, resources, and operational performance.
• Drive Lean maturity and a culture of Operational Excellence.
• Lead strategic transformation programs to boost capability and efficiency.
• Partner with R&D, Manufacturing, MSAT, Engineering, Quality, Automation, Supply Chain and Commercial for technology transfer and readiness.
• Evaluate new technologies and ensure state-of-the-art capabilities.
• Establish governance, metrics, and decision frameworks that support growth.
• Support site startup, expansion, validation, and capital investments as needed.

Skills

Leadership

Lean/Six Sigma

Strategic planning

Budget ownership

Cross-functional collaboration

Communication

Operational excellence

Education

Master's degree in engineering, Life Sciences, Chemistry, Pharmaceutical Sciences

PhD preferred

Tools

cGMP knowledge

Technology transfer

QMS software (TrackWise)

Job description

Director, Process & Analytical Development

Location: This position is currently remote. A future transition to an on-site location on the U.S. East-Coast/Mid-West is anticipated as the project progresses, with an expected timeline in 2027. This is a full-time role with a Monday–Friday schedule from 8:00 a.m. to 5:00 p.m.

What you will get:

The full-time base annual salary for this position is expected to range between $196,700 to $232,650. In addition, below you will find a comprehensive summary of the benefits package we offer:

• Performance-related bonus.

• Medical, dental and vision insurance.

• 401(k) matching plan.

• Life insurance, as well as short-term and long-term disability insurance.

• Employee assistance programs.

• Paid time off (PTO).

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

What will you do:

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.

• 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.

What we are looking for:

• 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.

• Travel: Willingness and ability to travel to EMEA and NA at approximately 25-30% of the time to meet business objectives.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.