Description

Our client is an innovative biotechnology startup company focused on the development of cutting-edge biologics to address high unmet medical needs. With a highly experienced leadership team and promising pipeline, the company is entering late-stage preclinical development and preparing for regulatory submission.

Our client is an innovative biotechnology startup company focused on the development of cutting-edge biologics to address high unmet medical needs. With a highly experienced leadership team and promising pipeline, the company is entering late-stage preclinical development and preparing for regulatory submission.

Description

As CMC Program Manager 80-100% (d/f/m), you will play a key role in driving the Chemistry, Manufacturing, and Controls (CMC) strategy and execution for the company's lead biologic program. You will collaborate closely with external Contract Development & Manufacturing Organizations (CDMOs) to ensure robust, cGMP-compliant process development and manufacturing to support upcoming clinical trials.

This is a unique opportunity to shape critical CMC workstreams in a lean biotech environment - balancing operational oversight, program management, and technical input.

The CMC Program Manager (d/f/m) is responsible for the following task areas:

• Lead the planning, coordination, and execution of all CMC activities for the preclinical and early clinical stages, integrating development, manufacturing, quality, and regulatory efforts.
• Act as the primary liaison between internal teams and CDMO partners, ensuring alignment on timelines, program goals, deliverables, and smooth technology transfer.
• Oversee production campaigns and optimize manufacturing processes with CDMOs, ensuring quality, timelines, budgets, and cost efficiency.
• Develop, implement, and maintain CMC program plans, proactively identify risks and implement mitigation strategies, and track key milestones.
• Review and oversee documentation related to manufacturing activities, including batch records, scale-up and validation protocols, analytical methods, deviations, and process reports.
• Prepare and manage CMC documentation for regulatory submissions (, IND/CTA Module 3 sections).
• Provide forward-looking analysis to anticipate CMC challenges, guide program direction, and support development strategies.
• Report progress to management, contributing to overall program strategy and decision-making.

Profile

In order to be considered for the role, the selected candidate must have:

• University degree (MSc or PhD) in Biotechnology, Biochemistry, Bioprocess Engineering, or a related discipline.
• Solid experience (2+ years if PhD, 5+ years if MSc) in CMC development for biologics (large molecules, antibodies).
• Demonstrated expertise in analytical techniques required for phase-appropriate development of biologics.
• Proven track record in managing CDMO partnerships and outsourced manufacturing projects.
• Strong understanding of cGMP requirements and regulatory standards for early clinical development.
• Experience with process optimization and technology transfer.
• Excellent project management skills: planning, budgeting, and stakeholder coordination.
• Proactive, solution-oriented mindset with the ability to work in a dynamic, fast-paced biotech environment.
• Fluency in English; German is a plus but not mandatory.

Job Offer

Shape criitical CMC workstreams and drive the introduction of an innovative drug.

Fully onsite.

Some travel to Geneva involved.