Job Summary
The role is focused on leading the downstream process development and manufacturing strategies for biotherapeutics in clinical stages, specifically targeting antibodies, multispecifics, and antibody-drug conjugates (ADCs). The position entails overseeing various stages, including process development, scaling up production, and managing technology transfer with Contract Manufacturing Organizations (CMOs). Additionally, the role provides crucial technical and regulatory CMC (Chemistry, Manufacturing, and Controls) support, while ensuring the management of manufacturing quality and lifecycle activities.
Responsibilities
- Lead the downstream process development for clinical-stage biotherapeutics.
- Oversee the scale-up and production processes along with technology transfer activities.
- Provide technical guidance and support for regulatory CMC-related matters.
- Manage manufacturing quality and lifecycle activities effectively.
- Author necessary documentation to support product supply and compliance.
- Coordinate with both internal and external teams to meet product delivery timelines.
Qualifications
- A university degree in science or engineering.
- Minimum of 8 years of hands-on experience in biopharmaceutical process development and GMP operations, or an equivalent combination of education and experience.
- Experience working with CMOs is essential.
- Strong knowledge of current Good Manufacturing Practices (cGMP) and International Council for Harmonisation (ICH) standards.
- Familiarity with regulatory compliance for biological products.
- Demonstrated analytical, organizational, and collaborative skills across functions.
- Knowledge of Quality by Design (QbD), control strategies, multivariate analysis, or Design of Experiments (DoE) is advantageous.
