Description
* Innovative Swiss Biotech Startup
* Unique Try&Hire opportunity
## About Our Client ##
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.
## Job 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 (e.g., 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.
## The Successful Applicant ##
**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, e.g. 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.
## What's on Offer ##
Shape criitical CMC workstreams and drive the introduction of an innovative drug.
Fully onsite.
Some travel to Geneva involved.
Quote job ref
JN-082025-6820059
Job Function
Healthcare & Life Sciences
Specialisation
Biotechnology
Industry
Healthcare / Pharmaceutical
Location
Zürich
Contract Type
Interim
Job Reference
JN-082025-6820059