Monoclonal Antibody Development Manager

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