Do you have a passion for production and enjoy working with many stakeholders both internally and externally? Would you like to bridge the gap between our internal sites and our Contract Manufacturing Organizations (CMOs) to ensure consistency across our operations? Then look no further: apply today and join our growing Global Contract Manufacturing (GCM) Drug Product (DP) External Manufacturing Technology and Optimization (EMTO) department. You might be the Senior Professional Aseptic Process (AP) DP EMTO AP we are looking for. The Position As Aseptic Process Senior Professional EMTO, you will collaborate with EMTO specialists and senior professionals on technology transfer projects for pre-filled syringes, cartridges, and vials to our CMO partners. You will play a key role in implementing new products and processes at CMO sites, gaining in-depth knowledge of [xxxxx] processes and products while providing technical support to ensure smooth external production operations. The position has a high degree of independence. In this position, you will:
Get insight into the production operations and drive solutions whenever production disturbances occur. Work closely to our team of EMTO specialists, professionals, support and internal stakeholders ensuring the implementation of a robust production process at our CMO partners. Gain and hold extensive knowledge of the production including the formulation preparation, filling, inspection, the production equipment, facilities and other processes related to the manufacture. Have a strong interaction with [xxxxx] Manufacturing development areas. Provide procedural or process recommendations, offer necessary competencies, and address obstacles to ensure the team achieves its goals and delivers measurable results.. Several of the CMOs we currently work with are in project phases where extra focus is needed from a set of skilled professionals. The every-day work in GCM can shift in many directions and therefore it is good if you can approach new situations with an open mind. International collaboration is also an integrated part of this position; therefore, you will be given the opportunity to travel frequently within Europe, USA, Asia or Africa (expected around 25-30 days per year. Qualifications To be considered for this position, we expect you to: Hold at least a master’s degree within Pharmacy, Engineering, Chemical Engineering, or any other relevant field. Bring extensive practical experience in the pharmaceutical industry, particularly in the manufacturing of sterile drug products such as pre-filled syringes, cartridges, and vials. Have some knowledge with Lean 6 Sigma or equivalent, have experience working in technology transfer projects, and/or life cycle management projects within drug product manufacturing operations (i.e. Formulation, filling, inspection, etc). Possess solid GMP knowledge along with a strong understanding of drug product manufacturing practices, including aseptic filling processes, isolator technology, and quality management systems. Proficiency in both written and spoken English. Have previously worked in an international environment. As person you excel at building trust with stakeholders and naturally share relevant information with your project team and colleagues. With an analytical mindset and a structured approach, you effectively manage multiple activities. While you thrive working independently, you also value collaborating and sharing knowledge with your peers. About the Department GCM Drug Product is part of [xxxxx]’s Product Supply organization. We are responsible for all [xxxxx] contracts and license manufacturing of semi-finished and finished drug products to global markets. Our main office is in Taastrup, Denmark. The primary role of GCM organization is to monitor and control the production handled by external Contract Manufacturing Organizations, ensuring delivery of products from the CMOs to our respective customers. Our CMOs are in Central Europe, North America, East Asia and South Africa. We, in DP EMTO, bear the responsibility for the production, the facility including all equipment and the Quality Management System (QMS) at the CMOs throughout the TT project phase and we work closely with our GCM Operations team providing technical/expertise support during Commercial supply. The position is in GCM DP EMTO AP department, a team consisting of highly experienced specialists and professionals with strong knowledge and background in pharmaceutical sciences. You will become a part of an international, diverse and well-functioning team that enjoy solving problems in collaboration. Working at [xxxxx] We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. For employees at [xxxxx], life means many things – from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energize us to perform our best at work. Ultimately, life is why we’re all here - to ensure that people can lead a life independent of chronic disease. Contact For further information, please contact Julio Cesar Crepaldi Santiago GCM DP EMTO AP Director, at +[xxxxx]. Deadline 09 March 2025. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 14.2.2025, men kan have været deaktiveret og genaktiveret igen.
