Senior CMC Project Lead

IGI; Neuenburg; On-site; CHF 120,000 - 170,000; Full time

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.

Skills

Biologics CMC

External manufacturing

Cross-functional leadership

Stakeholder comms

Global experience

Job description

You will oversee a part of the CMC development activities and GMP manufacturing for our innovative bi-/multi-specific antibody programs, working closely with CDMOs, CROs, and cross-functional internal teams to ensure successful delivery of development milestones.

Key Responsibilities

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

We are seeking a collaborative and results-oriented professional with:

• Strong experience in biologics CMC development and external manufacturing management.
• Proven ability to manage complex cross-functional projects and external partnerships.
• Excellent communication, stakeholder management, negotiation, and problem-solving skills.
• Experience working within a global, dynamic, and innovative environment.