Development manager II (CMC)

Responsibilities

• Define product development strategies aligned with business goals.
• Create and maintain detailed development roadmaps, milestones, and budgets for each program.
• Manage and build strong relationships with vendors and partners to ensure timely and compliant supply. Lead vendor selection and contract negotiation with vendors (external / internal CDMOs and CROs). Collaborate with legal counsels to draft and maintain contracts with vendors.
• Act as process owner for development and manufacturing of assigned components. Design, develop and manage scalable production processes, including testing and release of ADS Licensing platform components across multiple CDMOs.
• Define and implement process and analytical development approaches for assigned ADS Licensing technology components.
• Oversee production activities and associated deliverables, including financial tracking, regulatory documentation, and compliance files for assigned components.
• Prepare, author, and review regulatory documentation in close collaboration with the Regulatory Affairs (RA) team.
• Collaborate closely with the project management department, and manage technical relationships with internal partners (QA, R&D, MTA) and external parties (licensees) as a subject matter expert (SME).
• Provide mentorship to junior team members as needed, and coordinate the efforts of various SMEs in a matrix environment for assigned projects / programs.

Requirements

• PhD in Biotechnology, Biopharmaceutical Sciences, Molecular biology, Biochemistry, Biomedical Sciences or related
• Minimum 4 years relevant work experience in the pharmaceutical or biotechnology industry, for example as a technical lead, CMC project manager, or scientist within a development and / or manufacturing environment.
• Technical knowledge on recombinant protein production (at GMP scale) using mammalian and / or microbial fermentation and the associated purification techniques.
• Experience with GMP is required; experience in regulatory pathways and process validation is considered a plus.
• Project management skills with experience in organizing, prioritizing, planning, and executing multiple projects and programs, and ability to lead cross-functional teams and influence without direct authority
• There is no visa sponsorship available for this role.
• Ready to shape the future of life sciences?

Additional Information

Development Manager II, Large Molecules D&M ADS Licensing Location : Oss The Development Manager leads and coordinates the end-to-end development of GlycoConnect and other components, from early-stage research through process scale-up and commercial manufacturing. Independently manage technology components, vendors and partners (internal and external) relationships while taking increasing responsibility for complex programs. 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 .

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