Senior Drug Product Specialist
hace 6 días
Senior Drug Product Specialist – Zealand Pharma Does it excite you to work with late-stage drug product manufacturing, and do you have experience with technical transfer, scale‑up, process validation, and CDMO collaborations? 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 Join Zealand Pharma as the new Senior Drug Product Specialist. In this role, you will play a key role in driving late‑stage drug product manufacturing—from technical transfer and scale‑up to process validation and commercial production. You will coordinate closely with external partners and Contract Development and Manufacturing Organizations (CDMOs), ensuring smooth communication and efficient execution of manufacturing projects. You will serve as the professional anchor and expert in your field and will be empowered to shape the manufacturing strategy and how the role is executed day‑to‑day, taking ownership and making decisions within your area. Key responsibilities Responsible for drug product manufacturing, including participation in technical transfer, scale‑up, and process validation within Development and Life Cycle Management projects. Oversee and coordinate manufacturing collaborations with drug product CDMOs, ensuring effective day‑to‑day communication, adherence to plans, and production oversight. Actively support and optimise GMP manufacturing activities at CDMO sites, including review of production documentation and critical deviations to ensure compliance with high manufacturing standards. Serve as a key member of the CMC team by integrating manufacturing insights into project planning and execution, driving progress toward regulatory approval and commercial success. Continuously seek improvements in manufacturing operations and internal processes. Be a key player in building the department, internal workflows, standards, and setting the direction of internal and external collaborations. Qualifications MSc/PhD in chemistry, biochemistry, pharmaceutical sciences, chemical engineering, or a related field. Minimum 3 years of experience in the pharmaceutical industry with direct involvement in drug product manufacturing operations, including hands‑on experience with filling activities and filling equipment (required). Proven experience in process upscaling, risk assessment (e.g., FMEA), and executing process validation (including PPQ batches) for drug products. In‑depth knowledge of GMP manufacturing practices and regulatory requirements in late‑stage CMC development. Strong collaboration skills with a track record of effective participation in cross‑functional teams; excellent written and verbal communication skills in English. A continuous‑improvement mindset with a willingness to embrace new challenges in manufacturing processes. Your new team and culture Join a newly formed department and collaborate with a range of experts within the Chemistry, Manufacturing and Controls (CMC) and Device areas. The culture is built on cross‑functional teamwork, strong engagement, and a friendly, fun atmosphere where contributions lead to shared success. We have a unique culture, characterised by excellent teamwork and strong engagement across the organisation. 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. Application Deadline Interested in bonding with us? Then please apply no later than January 07, 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. Contact For further information, please contact Head of Manufacturing , Rasmus Sandberg‑Schaal at . Equal Employment Opportunity Statement 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 the discovery and development of peptide‑based medicines. More than 10 drug candidates invented by Zealand Pharma have advanced into clinical development, of which two have reached the market and three candidates are in late‑stage development. The company has development partnerships with a number of pharma companies as well as commercial partnerships for its marketed products. Zealand Pharma was founded in 1998 and is headquartered in Copenhagen, Denmark, with a team in the U.S. For more information about Zealand Pharma's business and activities, please visit . #J-18808-Ljbffr
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San Juan de Sumapaz, Colombia Zealand Pharma A tiempo completoA biotechnology company is seeking a Senior Drug Product Specialist in Colombia, specializing in late-stage drug product manufacturing. The ideal candidate has an MSc/PhD and a minimum of 3 years' experience in drug product operations, including technical transfers and process validations. Responsibilities include overseeing collaborations with CDMOs and...
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