Role Overview
We are seeking a Monoclonal Antibody Development Manager to lead the development and optimisation of antibody-based therapeutics from early development through clinical manufacturing.
This role sits at the intersection of process development, CMC strategy, and external manufacturing, and will play a critical role in advancing biologics programmes from concept to clinic.
Key Responsibilities
* Lead upstream and/or downstream process development for monoclonal antibodies
* Drive process optimisation, scale-up, and transfer into GMP manufacturing
* Support technology transfer activities to CDMOs and manufacturing sites
* Contribute to CMC strategy and regulatory documentation (IND/CTA, Module 3)
* Collaborate cross-functionally with MSAT, QA/QC, and Regulatory teams
* Manage external partners and CDMOs to ensure delivery against timelines
Requirements
Education
* PhD or MSc in Biochemistry, Biotechnology, Chemical Engineering, or a related field
Experience
* 5–10+ years of experience in biologics or monoclonal antibody development
* Proven experience in process development (upstream and/or downstream), GMP manufacturing, and technology transfer
* Experience supporting CMC activities for clinical-stage programmes
Technical Expertise
* Strong knowledge of monoclonal antibody production using mammalian expression systems such as CHO cells
* Experience with purification technologies, including chromatography and filtration
* Understanding of Quality by Design (QbD) principles, including QTPP, CQAs, and CPPs
* Familiarity with regulatory expectations for biologics development
Key Competencies
* Strong leadership and stakeholder management skills
* Ability to operate in a fast-paced, innovative biotech environment
* Strategic thinking combined with strong problem-solving ability
* Excellent communication and cross-functional collaboration skills
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