Development Manager II, Small Molecule CMC

Location: Oss

Synaffix (now part of Lonza) is a biotech company with a clinical-stage platform technology that enables best-in-class antibody-drug conjugates (ADCs), bispecific antibodies and other targeted therapeutics under a technology out-licensing business model. Synaffix was fully acquired by Lonza in June 2023. Aimed at enabling innovative medicines for patients in areas of high unmet medical need, Synaffix has forged a growing number of collaborations with top tier biotech and pharma companies by enabling best-in-class therapeutic candidates for their pipelines.

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 will get: 

• An agile career and dynamic working culture. 
• An inclusive and ethical workplace. 
• Compensation programs that recognize high performance. 
• A variety of benefits dependent on role and location. 

The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits.  

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.

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 value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.