Note: The job is a remote job and is open to candidates in USA. Lonza is a global life sciences company that manufactures medicines and supports the development of breakthrough therapies. The Director, Process & Analytical Development will lead the ADPD organization, oversee analytical and process development and project-specific manufacturing activities, and drive strategic planning, operational readiness, growth, and continuous improvement.
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
Skills
- 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 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
- PhD preferred
Benefits
- 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).
- Remote work initially, with a future transition to an on-site location on the U.S. East Coast/Midwest anticipated as the project progresses.
Company Overview
Company H1B Sponsorship