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.
What you’ll do:
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.
What we’re looking for:
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.
Synaffix 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.
At Lonza, our people are 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.
