Strategic Development Manager, Small Molecule CMC

Lonza Group Ltd.; Oss; On-site; EUR 61,000 - 85,000; Full time

Benefits offered by this job

Agile culture

Inclusive workplace

Compensation programs

Global benefits

Job summary

Lonza Oss (Synaffix) is seeking a Development Manager II to lead development and manufacturing strategy for small molecule CMC components in Oss, NL. You will own development roadmaps, manage CDMOs, and ensure compliant supply across clinical programs.

The role requires a PhD in chemistry or related field, 5–10 years in pharma development, and strong cross-functional leadership. Expect collaboration with Regulatory Affairs, QA, and external partners to drive programs forward.

Qualifications

• 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 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.

Responsibilities

• 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.

Skills

Project management

Cross-functional leadership

GMP experience

Vendor management

Communication

Stakeholder management

Education

PhD in Chemistry

Job description

Lonza Oss (Synaffix) is seeking a Development Manager II to lead development and manufacturing strategy for small molecule CMC components in Oss, NL. You will own development roadmaps, manage CDMOs, and ensure compliant supply across clinical programs.

The role requires a PhD in chemistry or related field, 5–10 years in pharma development, and strong cross-functional leadership. Expect collaboration with Regulatory Affairs, QA, and external partners to drive programs forward.