CMC Program Lead -Try&Hire

CMC Program Lead (Biologics) -Try&Hire (a)As CMC Program Manager, 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.CMC Program Lead (Biologics) -Try&Hire (a)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.DescriptionAs CMC Program Manager, 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 Manager (a) 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.ProfileUniversity degree (MSc or PhD) in Biotechnology, Biochemistry, Bioprocess Engineering, or a related discipline.Minimum 10+ years experience 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.Job OfferAre you interested in contributing your CMC skills to an exciting and fast-growing biotech start-up?If so, I look forward to receiving your application. jid7fc3c7dpn jit0209pn jiy26pn