Specialist Downstream Processes of Synthetic Peptides & Contract Manufacturing
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Bagsværd
Are you a skilled downstream purification scientist and want to be part of process transfer, implementation and validation activities at our contract manufacturing organizations (CMOs)? Then you could be our new colleague in Bagsværd.The positionWe are looking for a Specialist who has a strong scientific and technical background within downstream purification and drying processes for pharmaceutical manufacturing at scale.The preferable candidate is experienced in downstream processing for peptide-/protein-based therapeutics, incl. scale-up, process transfers and at-scale manufacturing. Technical and practical experiences with equipment implementation, column-packaging, and automation is strongly preferred. Experience with working in cGMP regulated manufacturing areas (preferably for commercial processes) is required.Your main task will include the following:Provide scientific and technical stewardship for the downstream process during process transfer and batch execution at CMOs for synthetic peptide projects. Common tasks include the evaluation of proposed technical designs (e.g. equipment trains, handling and unit operations) and plans for manufacturing processes performed in collaboration with our CMOs. Participate in cross-organizational groups and take responsibility for assigned deliverables in the technical transfer, batch execution/evaluation, and process validation. Act as process, product and equipment subject matter expert in cross-functional projects to support the timely finalization of scientific and technical documentation, conducted with the right scientific level. Provide critical scientific and technical support and troubleshooting for process execution at CMOs Comment on process/equipment changes and deviations Participate in systematic problem solving Collaborate as an author/Co-author, reviewer, and input provider to regulatory registration documents This job gives you a unique opportunity to work with multiple stakeholders including Downstream Development, analytical teams, Global Contract Manufacturing (GCM), QA, RA, Sourcing, pilot facilities, production facilities, and external partners.Travel activities are to be expected, approximately 20%. The position does not involve practical work in the laboratory.QualificationsTo succeed in the role, we expect that you have some of the below qualification and is eager to learn any remaining required skillset:Ph.D. within chemical or biochemical sciences, chemical engineering or equivalent. Extensive experience with downstream purification of peptide-/protein-based therapeutics within commercial phase and/or late development phase drug substance manufacturing Experience with different drying techniques, freeze drying, spray drying and precipitation. High level of relevant GMP experience and understanding of GMP requirements for drug substance manufacturing Experience with scale-up and process transfer to large scale manufacturing is required Good technical and practical knowledge of equipment and automation. Good practical understanding of unit operations (at scale) associated with chromatographic separation, filtration techniques. and preferably also drying methods Experience working with CMOs or within a CMO is an advantage Solution-oriented with strong practical capability to convert theory into practical solutions for technical challenges Ability to communicate and collaborate effectively with both internal and external stakeholders across disciplines in development and production, Positive attitude with the ability to work efficiently both as a team player and independently on complicated tasks ensuring timely progress About the departmentAs part of ’s Product Supply organization, you will be assigned to Emerging Technologies API Manufacturing Science and Technology (ET API MSAT). We work at the interface between CMC and full-scale manufacturing with a focus on process understanding, implementation, optimization, and life cycle management.
We offer a very interesting and varying job with the opportunity to work with other highly qualified and motivated colleagues in a multidisciplinary project environment.Working at At , your skills, dedication, and ambition help us change lives for the better. In exchange, we offer unique possibilities for professional, personal, and scientific development in state-of-the-art facilities, an informal working environment, and the chance to integrate into a dynamic team of highly qualified and enthusiastic colleagues.ContactFor further information, please contact manager, Dan Killander, at +Deadline3 August 2025Applications are reviewed on an ongoing basis, so please submit your application as soon as possible.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 process, please refrain from adding a photo and submit your CV in English.We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.At 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.
We offer a very interesting and varying job with the opportunity to work with other highly qualified and motivated colleagues in a multidisciplinary project environment.Working at At , your skills, dedication, and ambition help us change lives for the better. In exchange, we offer unique possibilities for professional, personal, and scientific development in state-of-the-art facilities, an informal working environment, and the chance to integrate into a dynamic team of highly qualified and enthusiastic colleagues.ContactFor further information, please contact manager, Dan Killander, at +Deadline3 August 2025Applications are reviewed on an ongoing basis, so please submit your application as soon as possible.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 process, please refrain from adding a photo and submit your CV in English.We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.At 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.
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Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Bagsværd.
Jobbet er oprettet på vores service den 7.7.2025, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
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