Senior Drug Product Filling Specialist

Job description

Does it excite you to work with aseptic drug product filling for peptide medicines, and do you have deep experience with RABS and isolator filling lines? If this sounds like you, and you are ready to take on a broad area of responsibilities, then you could be our new colleague. Your new position As Senior Drug Product Filling Specialist, you will be our subject matter expert in aseptic filling of prefilled syringes (PFS) and vials on RABS and isolator lines. Zealand Pharma works with contract development and manufacturing organizations (CDMOs) as drug product production partners, and you will be a key contact and coordinate the manufacturing collaborations with these partners. You will ensure effective day-to-day communication, adherence to oversight plans, and seamless transfer of technical knowledge, while supporting GMP manufacturing activities. We offer exciting responsibilities: Act as technical expert for aseptic filling processes on RABS and isolator lines for PFS and vials, including manual and automated visual inspection processes Serve as key contact and coordinate manufacturing collaborations with DP CDMOs, ensuring effective day-to-day communication Ensure adherence to oversight plans and drive the transfer of technical knowledge, including technology transfer, process validation, and scale-up Support GMP manufacturing activities at CDMOs, including review and approval of batch records, filling-related documentation, and inspections Lead or support investigations of deviations and change controls related to filling and aseptic processing, including root cause analysis and CAPA (corrective and preventive actions), and contribute to contamination control strategy and aseptic process simulations (media fills) Act as a key member of the Chemistry, Manufacturing and Controls (CMC) team by integrating manufacturing insights into project planning and execution for phase 1, 2 & 3, and supporting regulatory approval and commercial processes Your profile You are a hands-on, curious, and structured professional who combines deep technical knowledge with sound judgement, and who is a strong communicator and relationship builder. You thrive in an environment where teamwork, cross-functional collaboration, and good colleagues are at the core of everything, and where true empowerment and a “Yes we can” mindset are a must. You take ownership, stay calm in demanding situations, and enjoy sharing your expertise with colleagues and external partners. Extensive experience in aseptic drug product filling within the pharmaceutical or biotech industry Solid hands-on experience with both RABS and isolator filling lines Proven experience with filling of both PFS and vials Strong knowledge of GMP, including EU GMP Annex 1 and contamination control principles Experience with CDMO or external partner oversight, technology transfer, validation, and deviation management in a regulated environment Relevant academic background, e.g. M.Sc. or Ph.D. in pharmaceutical sciences, engineering, or a related field, and fluency in English Your new team You will be joining a newly established team and will be working together with a range of experts within the CMC area. The Manufacturing department is established to facilitate and support projects in all clinical phases and life cycle management of products on the market. The department covers end-to-end manufacturing from active pharmaceutical ingredient to packed device, and collaborates closely with development departments, QA, and the projects. Let’s bond and be bold We have a unique culture, characterized by excellent teamwork and strong engagement across the organization. And we want you to help us strengthen this culture. Making bonds is at the core of everything we do. From discovering and developing the best new peptide drugs for patients, to engaging with our partners or connecting with each other. We bond through curiosity and playfulness as a team, allowing ourselves to challenge common thinking and drive future innovation. Join us and let’s bond and be bold. Interested in bonding with us? Then please apply no later than October 31, 2026, or as soon as possible. The applications will be reviewed as they come in. While a cover letter is not required, please include a few sentences in your CV explaining your motivation for applying. For further information, please contact Head of Manufacturing, Rasmus Sandberg-Schaal, RSSchaal@zealandpharma.com. We are committed to an inclusive recruitment process and welcome applications from all job applicants. About Zealand Pharma A/S Zealand Pharma A/S (Nasdaq: ZEAL) is a biotechnology company focused on advancing medicines for obesity and metabolic health. Combining more than 25 years of peptide R&D expertise with a proprietary data platform that leverages advanced data-driven and AI/ML approaches, Zealand Pharma aims to lead a new era in obesity and metabolic health. To date, more than ten Zealand Pharma-invented drug candidates have entered clinical development, of which two products have reached the market and three candidates are in late-stage development. The Company has collaborations with global pharmaceutical and biotechnology partners for research, development, and commercialization. Founded in 1998, Zealand Pharma is headquartered in Copenhagen, Denmark, with a U.S. presence in Boston, Massachusetts. Learn more at www.zealandpharma.com. #LI-Onsite