Development Manager II

Lonza

Oss, Netherlands

We have an exciting opportunity available for a Development Manager II within the Development and Manufacturing (DAM) Department at Lonza Oss (Synaffix). The DAM department is responsible for the development, manufacturing, supply, and lifecycle management of the proprietary technology components that support our partners' drug development programs. The Development Manager II acts as process owner for one or more platform components and is responsible for defining development strategies, managing external manufacturing networks, and ensuring reliable supply throughout clinical development and beyond. The role requires close collaboration with internal stakeholders and external partners to drive program execution while maintaining compliance with quality, regulatory, and business requirements. The Development Manager II also supports technical interactions with licensees and contributes to aligning supply strategies with future clinical development needs.

What you’ll do:

Define product development strategies aligned with business goals and create development roadmaps, milestones, and budgets for assigned technology components.
Manage and build strong relationships with vendors and partners to ensure timely and compliant supply of Synaffix technology components. Lead vendor selection activities and contract negotiations in collaboration with Legal and other stakeholders.
Act as process owner for development and manufacturing of assigned components. Design, develop, and manage scalable production processes, including testing and release activities across multiple CDMOs.
Define and implement process and analytical development strategies for assigned technology components.
Oversee manufacturing campaigns and associated deliverables, including financial tracking, regulatory documentation, quality documentation, and compliance activities.
Prepare, author, and review regulatory documentation in close collaboration with Regulatory Affairs. Responsibilities may include ownership or co-authorship of assigned dossier sections.
Support technical relationships with licensees and collaborate with the Oss Project Management team to ensure supply aligns with licensees' clinical development requirements and demand forecasts.
Collaborate closely with Quality Assurance, Regulatory Affairs, R&D, Manufacturing Technology & Analytics, and other cross-functional stakeholders to ensure successful execution of development and manufacturing activities.
Provide mentorship to junior team members and coordinate the contributions of subject matter experts in a matrix environment.
Support strategic initiatives and continuous improvement activities across the Development and Manufacturing Department.

What we’re looking for:

PhD in Chemistry, Organic Chemistry, Pharmaceutical Chemistry or a related discipline.
5-10 years of relevant industry experience in pharmaceutical development, process development, CMC, or GMP manufacturing.
Strong technical knowledge of synthetic organic chemistry and pharmaceutical manufacturing processes.
Proven project and program management experience, including planning, prioritization, budgeting, and execution of multiple parallel activities.
Experience managing external development and manufacturing partners, including CDMOs and CROs.
Ability to lead cross-functional teams and influence stakeholders without direct authority.
Experience with GMP manufacturing, ICH guidelines, and pharmaceutical regulatory requirements.
Candidates with hands-on experience in small molecule API process development, process scale-up, and GMP manufacturing are strongly preferred.
Experience in CMC development and manufacturing of ADC linker-payloads, highly potent compounds (HPAPIs), or related technologies is desirable.
Excellent communication skills and the ability to build productive relationships with internal and external stakeholders.