Ardena Södertälje AB jobb

Introduction to Ardena As a leading Contract Development and Manufacturing Organization (CDMO), Ardena partners with pharmaceutical companies of all sizes—from emerging biotech to global industry leaders—united by the mission to help biopharma innovators navigate drug development with precision, quality, and speed, bringing their molecules from discovery to the clinic and market. Our fully integrated services span drug substance and drug product development, manufacturing, nanomedicine, clinical logistics, bioanalytical services, state research, fill & finish, and CMC regulatory support. With a rapidly growing international footprint, Ardena is home to over 750 professionals across six strategic locations—Belgium (Ghent), the Netherlands (Oss and Assen), Sweden (Södertälje), Spain (Pamplona), and Somerset, New Jersey (the US). Our open and transparent culture is built on collaboration, ownership, and innovation, guided by our We CARE values. We foster a communicative environment where mutual respect, accountability, and excellence empower our team. We are looking for skilled and motivated professionals eager to grow their careers in an exciting and fast-paced environment. Whether you’re an experienced expert or just starting out, Ardena provides a dynamic workplace where you can contribute to meaningful drug development projects, expand your knowledge, and be part of a global team committed to making a difference. As an international organization, we help you navigate a career path that expands your possibilities beyond borders, opening doors to personal and professional growth without limits. Your potential to grow is limitless with us. If you are ready to take on new opportunities, work alongside industry experts, and contribute to the future of medicine, Ardena is the place for you. For the Ardena Business Unit based in Sweden, Södertälje, we are looking for scientists, senior scientists and principal scientists to join the manufacturing department in permanent positions. A background within Organic Chemistry is required, it is meritorious with experience within the pharmaceutical industry and GMP. WHAT YOU WILL WORK ON As a scientist within the manufacturing team, you will work with the production of active pharmaceutical ingredients (APIs), the medicines of the future. The position involves reactor chemistry on large scale and potentially also preparative HPLC and distillation. YOUR ROLE As a Scientist/ Senior Scientist in the manufacturing team, you will play a pivotal role in the synthesis API’s, ensuring execution of projects in compliance with Ardenas manufacturing capabilities and regulations. You will work closely with the Process Development and Quality Control teams to deliver high-quality products that align with Ardena’s mission. YOUR KEY RESPONSIBILITIES Manufacturing of drug substance/active pharmaceutical ingredients (APIs), according to pre-approved procedures under GMP, that are to be used in clinical trials. Manufacturing of compounds for use within Life Science. Working with different types of equipment, reactor systems, preparative HPLC, large scale autoclave, distillation units. Performing in-process controls. Preparation of batch production records. Risk assessment of work to be performed. Handling of documentation, deviations, CAPA, change control. Investigation of deviations within the production department. General maintenance and cleaning of equipment after use. Writing scientific reports. Ensure compliance with latest development trends and insights, API manufacturing industry regulations, e.g., GMP. YOUR PROFILE You have an MSc or PhD degree in organic chemistry, chemical engineering or equivalent. A few years of relevant experience from the chemical or pharmaceutical industry, is a merit. Experience of working within regulated manufacturing, such as GMP, is a merit. You are a confident, independent, responsible and a curious person. You are flexible, a problem solver and a team player. You feel comfortable in a dynamic and changing environment. You have good communication skills and are fluent in English. Soft skills that align with our CARE values- Communicative, Accountable, Reliable, and Excellent. WHAT WE OFFER At Ardena, we recognize that our people drive our success. We offer: A true learning environment where you will have the ability to grow your skills. An attractive wellness allowance. Flexible working hours. A dynamic, international work environment with nice colleagues and caring culture. A chance to contribute to groundbreaking drug development projects that make a real impact. HOW TO APPLY Please submit your application no later than the 4th of July 2025. Make note that applicants of interest will be called for interview during the application duration and the positions may be filled before the final application date. Ready to start your career path with Ardena? Click the application button and join us in shaping the future of drug development! Only candidates eligible to work in the EU will be considered for the position. Unfortunately, given the high volume of applications we receive for our vacancies, these professionals (not entitled to work in the European Union) will not be given a status update. Agency calls will not be appreciated.

Introduction to Ardena As a leading Contract Development and Manufacturing Organization (CDMO), Ardena partners with pharmaceutical companies of all sizes—from emerging biotech to global industry leaders—united by the mission to help biopharma innovators navigate drug development with precision, quality, and speed, bringing their molecules from discovery to the clinic and market. Our fully integrated services span drug substance and drug product development, manufacturing, nanomedicine, clinical logistics, bioanalytical services, state research, fill & finish, and CMC regulatory support. With a rapidly growing international footprint, Ardena is home to over 750 professionals across six strategic locations—Belgium (Ghent), the Netherlands (Oss and Assen), Sweden (Södertälje), Spain (Pamplona), and Somerset, New Jersey (the US). Our open and transparent culture is built on collaboration, ownership, and innovation, guided by our We CARE values. We foster a communicative environment where mutual respect, accountability, and excellence empower our team. We are looking for skilled and motivated professionals eager to grow their careers in an exciting and fast-paced environment. Whether you’re an experienced expert or just starting out, Ardena provides a dynamic workplace where you can contribute to meaningful drug development projects, expand your knowledge, and be part of a global team committed to making a difference. As an international organization, we help you navigate a career path that expands your possibilities beyond borders, opening doors to personal and professional growth without limits. Your potential to grow is limitless with us. For the Ardena Business Unit based in Södertälje, we are looking for an Analytical Chemist for the role as Senior Scientist in Analytical Development as a permanent position. WHAT YOU WILL WORK ON Senior Analytical chemist in Analytical Development laboratory. YOUR ROLE As a Senior Scientist in Analytical Development laboratory, you will play a pivotal role in analytical development, ensuring execution of projects in compliance with Ardenas manufacturing capabilities and regulations. You will work closely with process development, QC, and manufacturing teams to deliver high-quality solutions that align with Ardena’s mission. YOUR KEY RESPONSIBILITIES You will be working as a senior team member in the analytical development team. You will independently develop analytical methods for testing of raw materials, intermediates and APIs. You will validate analytical methods to be used for GMP analysis of material for clinical studies. You will independently generate precise, reliable, and reproducible data. You will independently prepare analytical methods and report on the result from analytical method development. You will write and review validation protocols, data and reports. You will write and review specifications. You will approve and transfer analytical methods to the Quality Control group. You will qualify and implement pharmacopeia methods. You will be involved in quality control activities such as release testing and stability studies. You will collaborate with customers and other colleagues from R&D, manufacturing, quality control and quality assurance as to advance projects through development. You will be responsible to assure delivery against project timelines. You will be involved in laboratory design, analytical method transfers, and instrument re-location in the team expansion. YOUR PROFILE You have a university degree in Analytical Chemistry, Chemical Engineering, Biotechnology or similar. You have a minimum 2 years of experience in method development and/or method validation. You have a minimum of 2 years of experience in working with chromatography. You have at least 2 years experience in working in a cGMP/GLP environment. You have proficient knowledge/experience in working with analytical instrumentation, qualification procedures and troubleshooting. You have experience in reviewing instrument qualifications. You have experience in reviewing method validation and method development. Experience with Chromeleon (CDS) is a merit. Experience with titration techniques is a merit. You feel comfortable in a dynamic and changing environment. You have strong analytical and problem solving ability. You are flexible, a problem solver, and act as a senior team player. You have an analytical mindset and you can handle multiple projects at the same time. You have good communication skills and are fluent in English (written as well as spoken). WHAT WE OFFER At Ardena, we recognize that our people drive our success. We offer: A true learning environment where you will have the ability to grow your skills An attractive wellness allowance Flexible working hours A dynamic, international work environment with nice colleagues and caring culture A chance to contribute to groundbreaking drug development projects that make a real impact Please submit your application no later than the 23rdof April 2025. Only candidates eligible to work in the EU will be considered for the position. Unfortunately, given the high volume of applications we receive for our vacancies, these professionals (not entitled to work in the European Union) will not be given a status update. Agency calls will not be appreciated.

Introduction to Ardena As a leading Contract Development and Manufacturing Organization (CDMO), Ardena partners with pharmaceutical companies of all sizes—from emerging biotech to global industry leaders—united by the mission to help biopharma innovators navigate drug development with precision, quality, and speed, bringing their molecules from discovery to the clinic and market. Our fully integrated services span drug substance and drug product development, manufacturing, nanomedicine, clinical logistics, bioanalytical services, state research, fill & finish, and CMC regulatory support. With a rapidly growing international footprint, Ardena is home to over 750 professionals across six strategic locations—Belgium (Ghent), the Netherlands (Oss and Assen), Sweden (Södertälje), Spain (Pamplona), and Somerset, New Jersey (the US). Our open and transparent culture is built on collaboration, ownership, and innovation, guided by our We CARE values. We foster a communicative environment where mutual respect, accountability, and excellence empower our team. We are looking for skilled and motivated professionals eager to grow their careers in an exciting and fast-paced environment. Whether you’re an experienced expert or just starting out, Ardena provides a dynamic workplace where you can contribute to meaningful drug development projects, expand your knowledge, and be part of a global team committed to making a difference. As an international organization, we help you navigate a career path that expands your possibilities beyond borders, opening doors to personal and professional growth without limits. Your potential to grow is limitless with us. If you are ready to take on new opportunities, work alongside industry experts, and contribute to the future of medicine, Ardena is the place for you. For the Ardena Business Unit based in Södertälje, we are looking for an Analytical Chemist for the role as Scientist in Analytical Development as a permanent position. WHAT YOU WILL WORK ON Analytical chemist in Analytical Development laboratory. YOUR ROLE As a Scientist in Analytical Development laboratory, you will play a pivotal role in analytical development, ensuring execution of projects in compliance with Ardenas manufacturing capabilities and regulations. You will work closely with process development, QC, and manufacturing teams to deliver high-quality solutions that align with Ardena’s mission. YOUR KEY RESPONSIBILITIES You will be working in the analytical development team. You will be involved in developing analytical methods for testing of raw materials, intermediates and APIs. You will be involved in validation of analytical methods to be used for GMP analysis of material for clinical studies. You will independently generate precise, reliable, and reproducible data. You will be involved in preparing analytical methods and report result from the analytical method development work. You will write validation protocols, data and reports. You will write specifications. You will transfer analytical methods to the Quality Control group. You will qualify and implement pharmacopeia methods. You will be involved in quality control activities such as release testing and stability studies. You will collaborate with customers and other colleagues from R&D, manufacturing, quality control and quality assurance as to advance projects through development. You will be responsible to assure delivery against project timelines. You will be involved in laboratory design, analytical method transfers, and instrument re-location in the team expansion. YOUR PROFILE You have a university degree in Analytical Chemistry, Chemical Engineering, Biotechnology or similar. You have some experience in method development and/or method validation. You have a minimum of 1 year of experience in working with chromatography. You have at least 1 year experience in working in a cGMP/GLP environment. You have good knowledge/experience in working with analytical instrumentation, qualification procedures and troubleshooting. Experience from reviewing of instrument qualifications is a merit. Experience with Chromeleon Chromatography Data Software is a merit. Previous experience from reviewing method validation and method development work is a merit. You feel comfortable in a dynamic and changing environment. You have strong analytical and problem solving ability. You like to learn and develop yourself. You are flexible, a problem solver and a team player. You have an analytical mindset and you can handle multiple projects at the same time. You have good communication skills and are fluent in English (written as well as spoken). WHAT WE OFFER At Ardena, we recognize that our people drive our success. We offer: A true learning environment where you will have the ability to grow your skills An attractive wellness allowance Flexible working hours A dynamic, international work environment with nice colleagues and caring culture A chance to contribute to groundbreaking drug development projects that make a real impact Please submit your application no later than the 23rdof April 2025. Ready to start your career path with Ardena? Apply now and join us in shaping the future of drug development! Only candidates eligible to work in the EU will be considered for the position. Unfortunately, given the high volume of applications we receive for our vacancies, these professionals (not entitled to work in the European Union) will not be given a status update. Agency calls will not be appreciated.

Introduction to Ardena As a leading Contract Development and Manufacturing Organization (CDMO), Ardena partners with pharmaceutical companies of all sizes—from emerging biotech to global industry leaders—united by the mission to help biopharma innovators navigate drug development with precision, quality, and speed, bringing their molecules from discovery to the clinic and market. Our fully integrated services span drug substance and drug product development, manufacturing, nanomedicine, clinical logistics, bioanalytical services, state research, fill & finish, and CMC regulatory support. With a rapidly growing international footprint, Ardena is home to over 750 professionals across six strategic locations—Belgium (Ghent), the Netherlands (Oss and Assen), Sweden (Södertälje), Spain (Pamplona), and Somerset, New Jersey (the US). Our open and transparent culture is built on collaboration, ownership, and innovation, guided by our We CARE values. We foster a communicative environment where mutual respect, accountability, and excellence empower our team. We are looking for skilled and motivated professionals eager to grow their careers in an exciting and fast-paced environment. Whether you’re an experienced expert or just starting out, Ardena provides a dynamic workplace where you can contribute to meaningful drug development projects, expand your knowledge, and be part of a global team committed to making a difference. As an international organization, we help you navigate a career path that expands your possibilities beyond borders, opening doors to personal and professional growth without limits. Your potential to grow is limitless with us. If you are ready to take on new opportunities, work alongside industry experts, and contribute to the future of medicine, Ardena is the place for you. For the Ardena Business Unit based in Södertälje, we are looking for an Analytical Chemist in the role as Scientist Quality Control for a temporary position (6 months) with the possibility of extension. WHAT YOU WILL WORK ON Analytical Chemist in Quality Control YOUR ROLE As a Scientist in Quality Control, you will play a pivotal role in Analytical Sciences, ensuring execution of projects in compliance with Ardenas manufacturing capabilities and regulations. You will work closely with analytical development and manufacturing teams to deliver high-quality solutions that align with Ardena’s mission. YOUR KEY RESPONSIBILITIES You will be working as a team member in the quality control team with GMP related deliveries and problem solving. You will perform and review analyses by HPLC/UPLC, GC, IR and Karl-Fisher. You will perform deviation investigations, write and implement change controls and CAPAs. You will write and review GMP documentation such as SOP:s. You will perform quality control of raw materials, intermediates and end products. You will issue Certificate of Analysis for non-GMP and GMP materials. You will perform out of specification investigations and writing analytical errors. You will be responsible to assure delivery against project timelines. You will collaborate with customers and other colleagues from R&D, manufacturing, quality control and quality assurance as to advance projects through development. You will be responsible to assure delivery against project timelines. YOUR PROFILE You have a university degree in Analytical Chemistry, Chemical Engineering, Biotechnology or similar. You have at least 2 years of previous experience from work in a cGMP environment, including writing and reviewing GMP documentation. You have experience from work with chromatography. Previous experience from reviewing GMP documentation is a merit. You feel comfortable in a dynamic and changing environment. You are a proactive person and like to learn and develop yourself. You are flexible, a problem solver and a team player. You have an analytical mindset, and you can handle multiple projects at the same time. You have good communication skills and are fluent in English (written as well as spoken) WHAT WE OFFER At Ardena, we recognize that our people drive our success. We offer: A true learning environment where you will have the ability to grow your skills An attractive wellness allowance Flexible working hours A dynamic, international work environment with nice colleagues and caring culture A chance to contribute to groundbreaking drug development projects that make a real impact HOW TO APPLY Please submit your application no later than the 23rd of April 2025. Ready to start your career path with Ardena? Click the application button and join us in shaping the future of drug development! Only candidates eligible to work in the EU will be considered for the position. Unfortunately, given the high volume of applications we receive for our vacancies, these professionals (not entitled to work in the European Union) will not be given a status update. Agency calls will not be appreciated.

Introduction to Ardena As a leading Contract Development and Manufacturing Organization (CDMO), Ardena partners with pharmaceutical companies of all sizes—from emerging biotech to global industry leaders—united by the mission to help biopharma innovators navigate drug development with precision, quality, and speed, bringing their molecules from discovery to the clinic and market. Our fully integrated services span drug substance and drug product development, manufacturing, nanomedicine, clinical logistics, bioanalytical services, state research, fill & finish, and CMC regulatory support. With a rapidly growing international footprint, Ardena is home to over 750 professionals across six strategic locations—Belgium (Ghent), the Netherlands (Oss and Assen), Sweden (Södertälje), Spain (Pamplona), and Somerset, New Jersey (the US). Our open and transparent culture is built on collaboration, ownership, and innovation, guided by our We CARE values. We foster a communicative environment where mutual respect, accountability, and excellence empower our team. We are looking for skilled and motivated professionals eager to grow their careers in an exciting and fast-paced environment. Whether you’re an experienced expert or just starting out, Ardena provides a dynamic workplace where you can contribute to meaningful drug development projects, expand your knowledge, and be part of a global team committed to making a difference. As an international organization, we help you navigate a career path that expands your possibilities beyond borders, opening doors to personal and professional growth without limits. Your potential to grow is limitless with us. If you are ready to take on new opportunities, work alongside industry experts, and contribute to the future of medicine, Ardena is the place for you. For the Ardena Business Unit based in Sweden, Södertälje, we are looking for a process development chemist in a role as Scientist or Senior Scientist for a temporary position (6 months) with the possibility of extension. WHAT YOU WILL WORK ON Organic chemist (skilled in organic synthesis) in Process Development laboratory YOUR ROLE As a Scientist/ Senior Scientist in Process Development laboratory, you will play a pivotal role in process development, ensuring execution of projects in compliance with Ardenas manufacturing capabilities and regulations. You will work closely with analytical development and manufacturing teams to deliver high-quality solutions that align with Ardena’s mission. YOUR KEY RESPONSIBILITIES Development of chemical processes, bringing them from lab scale to multi-kilogram scale Ensure compliance with latest development trends and insights, API manufacturing industry regulations, e.g., GMP Support technology transfers of the processes into our manufacturing facilities Participate in making process safety risk assessments for the lab and scale-up Writing scientific reports YOUR PROFILE You have a MSc or PhD degree in organic chemistry or similar You have a few years of experience from similar work You have strong problem-solving skills with a collaborative and solution-driven mindset You feel comfortable in a dynamic and changing environment You have good communication skills and are fluent in English (written as well as spoken) Soft skills that align with our CARE values- Communicative, Accountable, Reliable, and Excellent. WHAT WE OFFER At Ardena, we recognize that our people drive our success. We offer: A true learning environment where you will have the ability to grow your skills An attractive wellness allowance Flexible working hours A dynamic, international work environment with nice colleagues and caring culture A chance to contribute to groundbreaking drug development projects that make a real impact HOW TO APPLY Please submit your application no later than the 23rd of April 2025 Ready to start your career path with Ardena? Click the application button and join us in shaping the future of drug development! Only candidates eligible to work in the EU will be considered for the position. Unfortunately, given the high volume of applications we receive for our vacancies, these professionals (not entitled to work in the European Union) will not be given a status update. Agency calls will not be appreciated.

Introduktion till Ardena Som en ledande kontraktsutvecklings- och tillverkningsorganisation (CDMO) samarbetar Ardena med läkemedelsföretag av alla storlekar – från framväxande bioteknik till globala branschledare – förenade av uppdraget att hjälpa biofarmainnovatörer att navigera läkemedelsutveckling med precision, kvalitet och snabbhet, och föra sina molekyler från upptäckt till klinik och marknad. Våra helt integrerade tjänster spänner över utveckling av läkemedelssubstanser och läkemedelsprodukter, tillverkning, nanomedicin, klinisk logistik, bioanalytiska tjänster, statlig forskning, fyllning och finish samt CMC-regulatoriskt stöd. Med ett snabbt växande internationellt fotavtryck är Ardena hem för över 750 yrkesverksamma på sex strategiska platser – Belgien (Gent), Nederländerna (Oss och Assen), Sverige (Södertälje), Spanien (Pamplona) och Somerset, New Jersey (USA). Vår öppna och transparenta kultur bygger på samarbete, ägarskap och innovation, vägledd av våra We CARE-värderingar. Vi främjar en kommunikativ miljö där ömsesidig respekt, ansvarstagande och excellens stärker vårt team. Vi letar efter skickliga och motiverade proffs som är ivriga att utveckla sina karriärer i en spännande och fartfylld miljö. Oavsett om du är en erfaren expert eller precis har börjat, erbjuder Ardena en dynamisk arbetsplats där du kan bidra till meningsfulla läkemedelsutvecklingsprojekt, utöka dina kunskaper och vara en del av ett globalt team som är engagerat i att göra skillnad. Som en internationell organisation hjälper vi dig att navigera en karriärväg som utökar dina möjligheter över gränserna och öppnar dörrar till personlig och professionell tillväxt utan gränser. Din potential att växa är gränslös hos oss. Om du är redo att ta dig an nya möjligheter, arbeta tillsammans med branschexperter och bidra till medicinens framtid är Ardena platsen för dig. För vårbusiness unit baserad iSödertälje, letar vi nu efter en: Senior Material and Logistics Officer (Föräldravikariat) DIN ROLL Som Senior Material and Logistics Officer kommer du att spela en nyckelroll i hanteringen av kvalitetsdokument och logistik. Du kommer att arbeta självständigt men i nära samarbete med dina kollegor och avdelningschef. Din roll innebär att säkerställa att alla kvalitetsdokument är korrekt hanterade och att alla in- och utleveranser av gods sker effektivt och i enlighet med interna krav. OBS! Tjänsten är ett föräldravikariat på 6 månader. DINA PRIMÄRA ARBETSUPPGIFTER Ansvara för avdelningens kvalitetsdokument, inklusive säkerställa att alla dokument hanteras enligt gällande rutiner Säkerställa att dokumentation och spårbarhet är i ordning för alla produkter som hanteras, och följa upp på att alla kvalitetskrav efterlevs Säkerställa korrekt hantering av lagerflöden, inklusive inkommande och utgående varor Utföra inventeringar och kontrollera att lagerstatusen är korrekt och att lagernivåerna hålls på en optimal nivå Ha tät kontakt med leverantörer och partners Provtagning av råmaterial DIN PROFIL Har gymnasieutbildning Erfarenhet av administrativt arbete och stöd till ledning. God organisatorisk förmåga och förmåga att hantera flera projekt samtidigt. Starka kommunikationsfärdigheter i svenska samt engelska, både skriftligt och muntligt. Förmåga att arbeta självständigt såväl som i nära samarbete med andra. Positiv inställning och god förmåga att bygga relationer inom organisationen MERITERANDE Erfarenhet inom läkemedelsindustri Erfarenhet av att arbeta med kvalitetsdokumentation och följa regulatoriska krav Truckkort enligt TLP10, minsta krav: B1 (motviktstruck). VAD VI ERBJUDER På Ardena är vi medvetna om att det är våra medarbetare som driver vår framgång. Vi erbjuder: Flexibel arbetstid En dynamiskinternationell arbetsmiljö med möjligheter till karriärutveckling Tillgångtill Ardena Academy, vår interna lärplattform för professionell utvecklingEn chans att bidra till banbrytande läkemedelsutvecklingsprojekt som gör verklig skillnad SÅ HÄR ANSÖKER DU Vill du veta mer? Kontakta avdelningschef: Stefanie Olsson på [email protected]. Tjänsten är ett föräldravikariat från juni till november 2025. Är du redo att börja din karriär med Ardena? Klicka på ansökningsknappen och var med och forma framtidens läkemedelsutveckling!