Biologics CMC Program Lead - External Manufacturing

IGI

Neuenburg

On-site

CHF 120,000 - 170,000

Full time

3 days ago

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Job summary

IGI is seeking a collaborative, results-driven professional to oversee a portion of CMC development activities and GMP manufacturing for bi-/multi-specific antibody programs. The role will coordinate with CDMOs/CROs and internal teams to ensure milestones are delivered on time.

You will lead Cell Line Development, Upstream & Downstream Processing, Formulation, and Analytical Development through external partners, and supervise GMP manufacturing for clinical programs, ensuring regulatory

Qualifications

Deep experience in biologics CMC development and external manufacturing management.
Proven ability to manage complex cross-functional projects and external partnerships.
Excellent communication, stakeholder management and negotiation skills.

Responsibilities

Lead CMC development activities including Cell Line Development, Upstream & Downstream Processing, Formulation, and Analytical Development through external partners.
Oversee GMP manufacturing of drug substance and drug product for clinical programs.
Serve as primary contact for CDMOs/CROs, managing outsourced activities and timelines.
Drive technology transfer and external manufacturing activities as a key project team member.
Partner with CMC Strategy, Regulatory Affairs, and Project Management to ensure supply planning and regulatory readiness.
Present project progress, risks, and mitigation plans to senior leadership.
Contribute to budget planning, forecasting and critical CMC documentation.