Senior Production and CMC Manager (m/f)

Our client

hemotune AG is a Swiss medical device start-up company originating from ETH Zurich. The mission is to develop a lifesaving breakthrough medical device for targeted blood purification. Currently, the company is in the preclinical development phase and will now build up the production team for the clinical batches and planning the scale-up for commercial production.

Tasks

Your responsibilities

• You are responsible for the production activities for the magnetic core and polymer-coating of the nano-beads used in preclinical and clinical trials and the upcoming market launch.

• Lead the internal chemical production team of 4 people

• Coordinate manufacturing requirements (e.g., production slots, logistics) with project and business timelines, as well as suppliers and contract manufacturers

• Plan and support the scale-up from Pilot Plant to commercial production (in the coming years)

• Manufacturing process optimization together with R&D department (troubleshooting, deviation management and CAPAs)

• Review and release of manufacturing documentation, SOPs, logs, and reports

• Coordination of manufacturing and documentation activities with external and internal stakeholders

• Oversee production infrastructure and measuring equipment maintenance

• Oversee storage and shipping of raw materials, intermediates and final products

• Planning and performance of process validations, organization and review of risk assessments for process related changes

• CMC Subject Matter Expert and Point of Contact for colleagues and support in the creation of regulatory documents and meetings with regulatory authorities

• If possible: Scientific evaluation of results from product characterization and stability studies

Requirements

Your profile

• Scientific Degree (master / PhD) in Chemistry, Biochemistry or a related field
• At least 5 to 7 years of experience in the production of chemical, pharmaceutical products or API manufacturing
• Advanced knowledge of ISO 13485 or GMP requirements for combined medical products or drug manufacturing
• Good understanding of the review and release processes of manufacturing documentation
• Leadership experience of a small team, very good organizational and project management skills
• Highly self-motivated, independent generalist with a hands-on attitude
• Fluency in English, German is highly desired

Benefits

Your benefits

• a unique opportunity to be part of bringing a live-saving therapy to the market that will change the medical landscape.
• a dynamic work environment in an award-winning and highly motivated start-up team, with flat hierarchies and lots of room for self-realization and implementation of your ideas
• an exciting and modern workplace at Bio-Technopark Schlieren, easily reachable by public transport from Zurich HB
• up to 2 days of remote work per week