Drug Substance External Manufacturing Operations Lead

External Manufacturing Operations Lead

Location: Braine l'Alleud, Belgium (40% Onsite)

BioTalent is collaborating with a leading global biopharmaceutical company to find an External Manufacturing Operations Lead to join their team. This role will involve leading and managing the operational processes with global CMOs, overseeing complex projects, and optimizing manufacturing operations for new and existing drug products. Please note: applicants must have the right to work in Belgium without sponsorship and be able to travel globally.

Key Responsibilities:

• Lead daily operations and vendor teams across multiple functions.
• Manage CMO selection, technology transfers, process improvements, and new product introductions for New Chemical Entities.
• Provide technical expertise to optimize processes, validate CMOs, and ensure high-quality standards.
• Troubleshoot technical and supply issues, leading investigations and CAPA implementation.
• Develop operational and commercial strategies, monitor CMO capacity, and manage long-term product plans.

Experience & Skills:

• Master’s/PhD in Chemistry with 5+ years of relevant experience in a GMP Pharma environment.
• Expertise in Drug Substance manufacturing (small molecules, peptides a plus).
• Proven leadership in managing cross-functional teams and complex projects from development to commercialization.
• Strong external relationship management and problem-solving skills.
• Excellent English communication skills, both written and spoken.
• Ability to travel (approx. 20 days/year).

Ready to take on this exciting challenge? Apply today!