Head of Biologic Drug Substance - Process & Analytical Development

You will be responsible for

Strategic & Functional Leadership

1. Lead and oversee all Drug Substance Process & Analytical Development activities, setting strategy and ensuring organizational goals are met. Deliver integrated development plans for high-value biologic programs—early and late stage—on time, to budget, and with the required quality.
2. Direct the design, development, and optimization of robust, scalable, and compliant biopharmaceutical manufacturing processes.
3. Ensure ongoing compliance with global CMC regulations and implement evolving regulatory expectations, industry standards, and best practices.

Cross-Functional & Program Leadership

1. Partner with Clinical, Quality Assurance, Regulatory Affairs, Strategic Outsourcing, Operations, and Preclinical teams to ensure seamless, high-quality program execution and effective technology transfer to commercial manufacturing.
2. Lead strategic interactions with CDMOs. Manage external work packages, evaluate potential manufacturing partners, and drive end-to-end development strategies that integrate clinical, commercial, and regulatory priorities.
3. Champion innovation and continuous improvement across biologics development, introducing new technologies, methodologies, and scientific approaches that enhance performance and efficiency.

Technical & Analytical Excellence

1. Technical competence on Upstream and Downstream processes; experiences on Pilot facility in Cell culture (i.e. Mammalian, Bacterial, Vaccines, Peptides Biosimilars), Downstream, Engineering, Analytical & Characterization, Process Services; preferable experience on support late-stage process development, Scale-up / down, Technology Transfers and Regulatory procedures.
2. Assess and interpret complex data to guide scientific decisions, mitigate risks, and inform resource allocation and program strategy.
3. Communicate program status, development findings, and recommendations to senior leadership, internal partners, and regulatory agencies.
4. Provide hands-on leadership in technology transfer, scale-up, and process validation to ensure efficient transition from lab to clinical and commercial production.
5. Apply and promote Quality by Design (QbD) principles; contribute to the development of control strategies and validation plans.
6. Lead CMC contributions for regulatory submissions (MAA/NDA/BLA/JNDA) and support interactions with health authorities.