Upstream Process Scientist / Process Transfer

AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.

SUMMARY:

Maternity/temporary position - Upstream Process Scientist / Process TransferA challenging and varied job in our Process Transfer Department in Copenhagen as a 12-month temporary position is open for a quality-minded new colleague with mammalian upstream processing experience and a strong ability to drive interdepartmental collaboration.

The Job

AGC Biologics continues to enjoy great success, with a steadily increasing number of projects – many of which are late stage development projects preparing for commercial launch. More specifically, we have several projects active in the process validation stages from initial process risk assessment to execution of PPQ runs. At the same time, we are still handling many new and exciting customer projects and give support to processes already running in our GMP facility for clinical and commercial supply. With AGC Biologics increasing activities, we are looking for new colleagues with mammalian upstream processing experience.

Principal Responsibilities:

Depending on your level of qualification, you will from a position in Process Transfer take part in key activities for upstream development in mainly in mammalian processes and to a minor extend microbial processes and be responsible for:

  • Process transfers from customers and development into our manufacturing area

  • Support to GMP upstream manufacturing processes

The position offer interaction with a large number of stakeholders, and is unique in having contact with both our customers and all internal departments involved in process development, manufacturing and validation of upstream processes. You will be introduced to biopharmaceutical companies from all over the world and be an active player in their projects.  The daily challenges will vary a lot, and two days will never be the same.

The final job description will depend on the profile of our new colleague.

The Department

In our Process Transfer department, we are currently 11 highly skilled scientists, 3 student assistants, and 1 Director. We have an open communication and strong support and flexibility within the team.

The team is responsible for transfer of processes from customers to CMC Biologics and between development and manufacturing internally, as well as between CMC manufacturing sites globally (Denmark, United States, Germany, and Japan). Furthermore, the team is responsible for, and coordinates, process risk assessment and process validation activities. The team is recognized as a group of process subject matter experts and very often provides input in meetings with potential new customers and audits with authorities and costumers as SME’s.

KNOWLEDGE, SKILLS & ABILITIES

In our new colleague we’re looking for a person with:

  • Knowledge of process development and bioreactor design/technology

  • cGMP experience

  • Good English communication and collaborative people skills engaging with costumers and colleges of various cultural background, with an ability to obtain buy-in from all key stakeholders

  • A flexible approach and desire to take on and drive new tasks and responsibilities

  • Strong driver of interdepartmental tasks with the ability to keep the end goal in mind and prioritize between many different tasks

  • Preferable - experience in working with people from various cultures and background

EDUCATION/EXPERIENCE:

  • A minimum of 2 years’ experience with biopharmaceutical development and/or manufacturing

  • Experience with biopharmaceutical upstream mammalian bioproduction

AGC Biologics Copenhagen

AGC Biologics offers a dynamic working place and an excellent opportunity for working and growing with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a biologics contract development and manufacturing organization interact in order to achieve success. Exciting and challenging assignments will keep coming your way, but you will to a large extent be able to plan your daily work on your own. AGC Biologics offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC employees have a flexible attitude and we help each other to reach deadlines together as one team, complaint with our slogan - Right. On Time.

For further information please contact Henrik Næsted, Director of Process Transfer, hnaested@agcbio.com

We will process the applications in the order they arrive. Therefore please submit your application and CV as soon as possible.


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330028544Phoenix-6ca1498212019-05-21T00:00:00Upstream Process Scientist / Process Transfer

AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com.

SUMMARY:

Maternity/temporary position - Upstream Process Scientist / Process TransferA challenging and varied job in our Process Transfer Department in Copenhagen as a 12-month temporary position is open for a quality-minded new colleague with mammalian upstream processing experience and a strong ability to drive interdepartmental collaboration.

The Job

AGC Biologics continues to enjoy great success, with a steadily increasing number of projects – many of which are late stage development projects preparing for commercial launch. More specifically, we have several projects active in the process validation stages from initial process risk assessment to execution of PPQ runs. At the same time, we are still handling many new and exciting customer projects and give support to processes already running in our GMP facility for clinical and commercial supply. With AGC Biologics increasing activities, we are looking for new colleagues with mammalian upstream processing experience.

Principal Responsibilities:

Depending on your level of qualification, you will from a position in Process Transfer take part in key activities for upstream development in mainly in mammalian processes and to a minor extend microbial processes and be responsible for:

  • Process transfers from customers and development into our manufacturing area

  • Support to GMP upstream manufacturing processes

The position offer interaction with a large number of stakeholders, and is unique in having contact with both our customers and all internal departments involved in process development, manufacturing and validation of upstream processes. You will be introduced to biopharmaceutical companies from all over the world and be an active player in their projects.  The daily challenges will vary a lot, and two days will never be the same.

The final job description will depend on the profile of our new colleague.

The Department

In our Process Transfer department, we are currently 11 highly skilled scientists, 3 student assistants, and 1 Director. We have an open communication and strong support and flexibility within the team.

The team is responsible for transfer of processes from customers to CMC Biologics and between development and manufacturing internally, as well as between CMC manufacturing sites globally (Denmark, United States, Germany, and Japan). Furthermore, the team is responsible for, and coordinates, process risk assessment and process validation activities. The team is recognized as a group of process subject matter experts and very often provides input in meetings with potential new customers and audits with authorities and costumers as SME’s.

KNOWLEDGE, SKILLS & ABILITIES

In our new colleague we’re looking for a person with:

  • Knowledge of process development and bioreactor design/technology

  • cGMP experience

  • Good English communication and collaborative people skills engaging with costumers and colleges of various cultural background, with an ability to obtain buy-in from all key stakeholders

  • A flexible approach and desire to take on and drive new tasks and responsibilities

  • Strong driver of interdepartmental tasks with the ability to keep the end goal in mind and prioritize between many different tasks

  • Preferable - experience in working with people from various cultures and background

EDUCATION/EXPERIENCE:

  • A minimum of 2 years’ experience with biopharmaceutical development and/or manufacturing

  • Experience with biopharmaceutical upstream mammalian bioproduction

AGC Biologics Copenhagen

AGC Biologics offers a dynamic working place and an excellent opportunity for working and growing with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a biologics contract development and manufacturing organization interact in order to achieve success. Exciting and challenging assignments will keep coming your way, but you will to a large extent be able to plan your daily work on your own. AGC Biologics offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC employees have a flexible attitude and we help each other to reach deadlines together as one team, complaint with our slogan - Right. On Time.

For further information please contact Henrik Næsted, Director of Process Transfer, hnaested@agcbio.com

We will process the applications in the order they arrive. Therefore please submit your application and CV as soon as possible.

AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply, Right, On time. For more information, visit www.agcbio.com. SUMMARY: Maternity temporary position - Upstream Process Scientist Process TransferA challenging and varied job in our Process Transfer Department in Copenhagen as a 12-month temporary position is open for a quality-minded new colleague with mammalian upstream processing experience and a strong ability to drive interdepartmental collaboration. The Job AGC Biologics continues to enjoy great success, with a steadily increasing number of projects many of which are late stage development projects preparing for commercial launch. More specifically, we have several projects active in the process validation stages from initial process risk assessment to execution of PPQ runs. At the same time, we are still handling many new and exciting customer projects and give support to processes already running in our GMP facility for clinical and commercial supply. With AGC Biologics increasing activities, we are looking for new colleagues with mammalian upstream processing experience. Principal Responsibilities: Depending on your level of qualification, you will from a position in Process Transfer take part in key activities for upstream development in mainly in mammalian processes and to a minor extend microbial processes and be responsible for: Process transfers from customers and development into our manufacturing area Support to GMP upstream manufacturing processes The position offer interaction with a large number of stakeholders, and is unique in having contact with both our customers and all internal departments involved in process development, manufacturing and validation of upstream processes. You will be introduced to biopharmaceutical companies from all over the world and be an active player in their projects. The daily challenges will vary a lot, and two days will never be the same. The final job description will depend on the profile of our new colleague. The Department In our Process Transfer department, we are currently 11 highly skilled scientists, 3 student assistants, and 1 Director. We have an open communication and strong support and flexibility within the team. The team is responsible for transfer of processes from customers to CMC Biologics and between development and manufacturing internally, as well as between CMC manufacturing sites globally (Denmark, United States, Germany, and Japan). Furthermore, the team is responsible for, and coordinates, process risk assessment and process validation activities. The team is recognized as a group of process subject matter experts and very often provides input in meetings with potential new customers and audits with authorities and costumers as SME s. KNOWLEDGE, SKILLS ABILITIES In our new colleague we re looking for a person with: Knowledge of process development and bioreactor design technology cGMP experience Good English communication and collaborative people skills engaging with costumers and colleges of various cultural background, with an ability to obtain buy-in from all key stakeholders A flexible approach and desire to take on and drive new tasks and responsibilities Strong driver of interdepartmental tasks with the ability to keep the end goal in mind and prioritize between many different tasks Preferable - experience in working with people from various cultures and background EDUCATION EXPERIENCE: A minimum of 2 years experience with biopharmaceutical development and or manufacturing Experience with biopharmaceutical upstream mammalian bioproduction AGC Biologics Copenhagen AGC Biologics offers a dynamic working place and an excellent opportunity for working and growing with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a biologics contract development and manufacturing organization interact in order to achieve success. Exciting and challenging assignments will keep coming your way, but you will to a large extent be able to plan your daily work on your own. AGC Biologics offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC employees have a flexible attitude and we help each other to reach deadlines together as one team, complaint with our slogan - Right. On Time. For further information please contact Henrik Næsted, Director of Process Transfer, hnaested@agcbio.com We will process the applications in the order they arrive. Therefore please submit your application and CV as soon as possible.11jobnet6ca14982100000000000aDK_OFIR_02DKDanmark228DKK2019-06-18T00:00:000000https://chp.tbe.taleo.net/chp02/ats/careers/v2/viewRequisition?org=CMCICOS&cws=42&rid=13000EuropaDanmarkSjælland & øerStorkøbenhavnGladsaxe3516082AGC Biologics A/S11Vandtårnsvej 83B2860SøborgDKDanmark0
DKDanmarkDKDanmark
8Fuldtid46Permanent750724JobNet4980055498005510029-04-20190https://dispatcher.ofir.dk/statistic/register?context=FeedEntrySearchedCount&feedId=dc2beb84&entryId=6ca14982https://dispatcher.ofir.dk/statistic/register?context=FeedEntryDisplayCount&feedId=dc2beb84&entryId=6ca14982https://dispatcher.ofir.dk/statistic/register?context=JobApplicationInitiatedCount&feedId=dc2beb84&entryId=6ca14982&page=ShowJob&component=SendApplicationButtonhttps://dispatcher.ofir.dk/statistic/register?context=JobApplicationAppliedCount&feedId=dc2beb84&entryId=6ca14982&page=EmailApplyForm&component=SendApplicationButtonhttps://static.matchwork.com/company/logo/DK/ORS/SoMe/IT_Ingenioer_og_energi/Ingenioer_og_naturvidenskab/2.jpgØnsker du et spændende job med varierende arbejdsopgaver? Hos AGC Biologics A/S er dette netop hvad du bliver mødt af.12008071Dansk3Læse/ tale933169Bioanalytiker20Ingeniør og naturvidenskab361627601Henriknoreply@ofir.comDKDanmarkDKDanmark330032498Bioanalytiker til Klinisk Forskningsenhed og Hæmatologisk laboratorium, Herlev HospitalRobot Har du lyst til at arbejde i et højt fagligt miljø med engagerede kollegaer, så er denne stilling måske noget for dig. Laboratoriet ved Hæmatologisk afd. L søger en bioanalytiker med en ugentlig arbejdstid på 32 timer til besættelse d. 1 9-2019. Stillingen er vagtfri. Hvem er vi Vi er 2 enheder, Klinisk Forskningsenhed (KFE) og laboratoriet under Hæmatologisk afd. L på Herlev Hospital, som i fællesskab søger en bioanalytiker. KFE består af 1 ledende projektsygeplejerske, 1 overlæge, 5 sygeplejersker, en statistiker og en sekretær. Denne enhed tager sig af alle afdelingens kliniske protokoller. Laboratoriet er primært forankret som rutinelaboratorium for Hæmatologisk afdeling, som laver udredning og monitorering af hæmatologiske sygdomme. I laboratoriet er tilknyttet 8 bioanalytikere, 2 molekylærbiologer, 1 professor, 1 afdelingsbioanalytiker samt 1 sekretær. Hvad kan vi tilbyde Vi kan tilbyde jobbet, hvor du har indflydelse på din arbejdsdag. Hvor du arbejder meget selvstændigt. Hvor du er en central nøgleperson, som arbejder tværfagligt med mange forskellige faggrupper. Du vil have base i både Hæmatologisk KFE og Hæmatologisk Laboratorium. Jobbet vil være afvekslende og i et godt arbejdsmiljø blandt engagerede kollegaer. Dette er jobbet, hvor evner som selvstændighed, planlægningsevne og gode samarbejdsevner, struktur og fleksibilitet er i højsæde. Du kan forvente en grundig oplæring i alle dele af jobfunktionen, samt kurser i ICH GCP-regler. Arbejdsområde. Prøvehåndtering, pakning og forsendelse af protokolprøver Udfærdigelse af labmanualer til håndtering af protokolprøver Lagerstyring af laboratoriekit samt pakkemateriale Blodprøve og EKG tagning Deltagelse i initieringsmøder og udviklingsmøder Samarbejde med afdelingens læger og ph.d.-studerende omkring forskellige forskningsopgaver i laboratoriet Oprensning af DNA RNA og mononucleære celler til biobanker Opsætning af analyser i samarbejde med læger og ph.d.-studerende Vores forventninger til dig Du er uddannet bioanalytiker Er interesseret i at sætte dig ind i nye arbejdsopgaver og teknikker Kan arbejde selvstændigt, målrettet og løsningsorienteret med arbejdsopgaverne Er initiativrig, fleksibel og kan bevare overblikket Er omstillingsparat og interesseret i at arbejdsopgaverne udvikles Er udadvendt, positiv og besidder gode samarbejdsevner Taler, læser og skriver dansk samt engelsk Har kendskab til IT på brugerniveau, herunder office-programmer Ansøgningsfrist 20.06.2019 kl. 12 Samtaler afholdes onsdag d. 26. juni og onsdag d. 3. juli eller efter aftale. Har du spørgsmål til ovenstående er du velkommen til at kontakte afdelingsbioanalytiker Pia Taaning Petersen Tlf. 38682203Har du lyst til at arbejde i et højt fagligt miljø med engagerede kollegaer, så er denne stilling måske noget for dig.



Laboratoriet ved Hæmatologisk afd. L søger en bioanalytiker med en ugentlig arbejdstid på 32 timer til besættelse d. 1/9-2019. Stillingen er vagtfri.



Hvem er vi

Vi er 2 enheder, Klinisk Forskningsenhed (KFE) og laboratoriet under Hæmatologisk afd. L på Herlev Hospital, som i fællesskab søger en bioanalytiker. KFE består af 1 ledende projektsygeplejerske, 1 overlæge, 5 sygeplejersker, en statistiker og en sekretær. Denne enhed tager sig af alle afdelingens kliniske protokoller.

Laboratoriet er primært forankret som rutinelaboratorium for Hæmatologisk afdeling, som laver udredning og monitorering af hæmatologiske sygdomme. I laboratoriet er tilknyttet 8 bioanalytikere, 2 molekylærbiologer, 1 professor, 1 afdelingsbioanalytiker samt 1 sekretær.



Hvad kan vi tilbyde

Vi kan tilbyde jobbet, hvor du har indflydelse på din arbejdsdag. Hvor du arbejder meget selvstændigt. Hvor du er en central nøgleperson, som arbejder tværfagligt med mange forskellige faggrupper. Du vil have base i både Hæmatologisk KFE og Hæmatologisk Laboratorium. Jobbet vil være afvekslende og i et godt arbejdsmiljø blandt engagerede kollegaer. Dette er jobbet, hvor evner som selvstændighed, planlægningsevne og gode samarbejdsevner, struktur og fleksibilitet er i højsæde.

Du kan forvente en grundig oplæring i alle dele af jobfunktionen, samt kurser i ICH/GCP-regler.



Arbejdsområde.

  • Prøvehåndtering, pakning og forsendelse af protokolprøver
  • Udfærdigelse af labmanualer til håndtering af protokolprøver
  • Lagerstyring af laboratoriekit samt pakkemateriale
  • Blodprøve og EKG tagning
  • Deltagelse i initieringsmøder og udviklingsmøder
  • Samarbejde med afdelingens læger og ph.d.-studerende omkring forskellige forskningsopgaver i laboratoriet
  • Oprensning af DNA/RNA og mononucleære celler til biobanker
  • Opsætning af analyser i samarbejde med læger og ph.d.-studerende


Vores forventninger til dig

  • Du er uddannet bioanalytiker
  • Er interesseret i at sætte dig ind i nye arbejdsopgaver og teknikker
  • Kan arbejde selvstændigt, målrettet og løsningsorienteret med arbejdsopgaverne
  • Er initiativrig, fleksibel og kan bevare overblikket
  • Er omstillingsparat og interesseret i at arbejdsopgaverne udvikles
  • Er udadvendt, positiv og besidder gode samarbejdsevner
  • Taler, læser og skriver dansk samt engelsk
  • Har kendskab til IT på brugerniveau, herunder office-programmer




Ansøgningsfrist 20.06.2019 kl. 12



Samtaler afholdes onsdag d. 26. juni og onsdag d. 3. juli eller efter aftale.



Har du spørgsmål til ovenstående er du velkommen til at kontakte afdelingsbioanalytiker Pia Taaning Petersen Tlf. 38682203

Herlev HospitalHerlev2019-06-04T00:00:002019-06-20T00:00:00
330014981Bioanalytiker eller laborant med fokus på immunterapeutisk behandling af cancerpatienterRobot Nationalt Center for Cancer Immunterapi (CCIT-DK), Onkologisk Afdeling, Herlev Hospital søger med ansættelse fra 01.08.2019 eller snarest derefter en bioanalytiker eller laborant. Stillingen er på 37 t uge og arbejdstiden er 2 dage om ugen til kl. 16, mens arbejdstiden de øvrige dage er efter nærmere aftale. Arbejdsområde CCIT har i gennem en lang årrække arbejdet med at implementere egen grundforskning til eksperimentelle kliniske studier, der har til mål at behandle cancerpatienter med immunterapi ved at stimulere patientens eget immunforsvar til at angribe og bekæmpe kræftceller. Stillingen Arbejdsopgaven omfatter blandt andet: GMP-fremstilling af tumor-infiltrerende lymfocytter fra tumorvæv til patientbehandling GMP-fremstilling af peptid-vaccine til patientbehandling Håndtering og præparering af blodprøver blodceller Flow cytometriske analyser relateret til forskning- og udviklingsprojekter Arbejdet er meget selvstændigt og planlægges i tæt samarbejde med lederen af celleproduktionsenheden og tre bioanalytikere. En stor del af arbejdet foregår i GMP-klassificerede laboratorier i Herlev Hospitals Stamcellecenter. Løn- og ansættelsesvilkår følger overenskomsten for ikke-ledende personale på Sundhedskartellets område. Vi tilbyder et kreativt og ambitiøst team med forståelse for at de bedste resultater skabes i et godt arbejdsmiljø indflydelse og ansvar indenfor arbejdsområdet dygtige og interesserede kollegaer undervisning i nye teknikker og mulighed for personlig udvikling, herunder faglig udvikling inklusiv kursus- og kongresdeltagelse et arbejde, hvor du gør en vigtig forskel for behandlingen af patienter med cancer. Vi ønsker, at du er uddannet bioanalytiker eller laborant. er ambitiøs og har lyst til og let ved at lære nye ting. er grundig og har sans for detaljen. har gode samarbejdsevner, er fleksibel og ansvarsbevidst er selvstændig og kan planlægge din egen dag i samråd med nærmeste kolleger og seniorforsker gerne har erfaring med cellebiologiske og immunologiske teknikker gerne har erfaring med renrumsarbejde og eller flow cytometri er fleksibel i forhold til lejlighedsvis skæve arbejdstider i forbindelse med patientbehandling. Ansøgningsprocedure: Nærmere oplysninger om stillingen fås ved henvendelse til seniorforsker Özcan Met, telefon 38 68 92 29, e-mail: ozcan.met@regionh.dk Ansøgningsfristen er den 21.06.2019. Vi forventer at afholde samtaler i uge 26 Ansøgningen skal indeholde CV og dokumentation for relevant uddannelse og skal sendes online via linket herunder. Læs om CCIT-DK på: https: www.herlevhospital.dk ccit-denmark Sider default.aspxNationalt Center for Cancer Immunterapi (CCIT-DK), Onkologisk Afdeling, Herlev Hospital søger med ansættelse fra 01.08.2019 eller snarest derefter en bioanalytiker eller laborant. Stillingen er på 37 t/uge og arbejdstiden er 2 dage om ugen til kl. 16, mens arbejdstiden de øvrige dage er efter nærmere aftale.

Arbejdsområde
CCIT har i gennem en lang årrække arbejdet med at implementere egen grundforskning til eksperimentelle kliniske studier, der har til mål at behandle cancerpatienter med immunterapi ved at stimulere patientens eget immunforsvar til at angribe og bekæmpe kræftceller.

Stillingen
Arbejdsopgaven omfatter blandt andet:
  • GMP-fremstilling af tumor-infiltrerende lymfocytter fra tumorvæv til patientbehandling
  • GMP-fremstilling af peptid-vaccine til patientbehandling
  • Håndtering og præparering af blodprøver/blodceller
  • Flow cytometriske analyser relateret til forskning- og udviklingsprojekter
Arbejdet er meget selvstændigt og planlægges i tæt samarbejde med lederen af celleproduktionsenheden og tre bioanalytikere.

En stor del af arbejdet foregår i GMP-klassificerede laboratorier i Herlev Hospitals Stamcellecenter.

Løn- og ansættelsesvilkår følger overenskomsten for ikke-ledende personale på Sundhedskartellets område.

Vi tilbyder
  • et kreativt og ambitiøst team med forståelse for at de bedste resultater skabes i et godt arbejdsmiljø
  • indflydelse og ansvar indenfor arbejdsområdet
  • dygtige og interesserede kollegaer
  • undervisning i nye teknikker og mulighed for personlig udvikling, herunder faglig udvikling inklusiv kursus- og kongresdeltagelse
  • et arbejde, hvor du gør en vigtig forskel for behandlingen af patienter med cancer.
Vi ønsker, at du
  • er uddannet bioanalytiker eller laborant.
  • er ambitiøs og har lyst til og let ved at lære nye ting.
  • er grundig og har sans for detaljen.
  • har gode samarbejdsevner, er fleksibel og ansvarsbevidst
  • er selvstændig og kan planlægge din egen dag i samråd med nærmeste kolleger og seniorforsker
  • gerne har erfaring med cellebiologiske og immunologiske teknikker
  • gerne har erfaring med renrumsarbejde og/eller flow cytometri
  • er fleksibel i forhold til lejlighedsvis skæve arbejdstider i forbindelse med patientbehandling.
Ansøgningsprocedure:
Nærmere oplysninger om stillingen fås ved henvendelse til seniorforsker Özcan Met, telefon 38 68 92 29, e-mail: ozcan.met@regionh.dk
Ansøgningsfristen er den 21.06.2019. Vi forventer at afholde samtaler i uge 26
Ansøgningen skal indeholde CV og dokumentation for relevant uddannelse og skal sendes online via linket herunder.

Læs om CCIT-DK på: https://www.herlevhospital.dk/ccit-denmark/Sider/default.aspx


Herlev HospitalHerlev2019-06-04T00:00:002019-06-21T00:00:00
330039552Biostatistician to build and lead Radiometer's standards for BiostatisticsRobot Description You might be sitting with many ideas and a lot of motivation to drive the discipline of biostatistics. This is your chance to become our first internal Biostatistician that will contribute and advice on some of our most important development projects, influencing our strategy on how we obtain the most relevant medical claims. We are a leading provider of technologically advanced acute care solutions with more than 3,400 employees worldwide (1,100 in our Headquarters in Copenhagen Brønshøj). Welcome to Clinical Medical Affairs in Radiometer s R D organization You report to Director of Clinical Research, Fredrik Ceder, who works closely with the Clinical Operations team and the Medical Affairs team to set the direction for the strategy of our clinical studies. Using your statistical and Life Science expertize you can expect to become a vital advisor for the team. Your many R D-, Regulatory Affairs- and Marketing colleagues are also looking forward to working with you to develop our products in order to help caregivers even more in making diagnostic decisions that save lives. We have a good pipeline of studies planned and we expect that you will be engaged in studies related to Immunoassay Biochemistry, Cardiology and hematology to name some examples. Duties Responsibilities: - Provide statistical input to clinical team, study projects, and data management. - Consult with project teams and apply statistical expertise to ensure scientific validity and proper design of studies, prepare written summaries for use by regulatory agencies and project teams. - Provide statistical support to assist with sample size calculations and data analyses for clinical studies. - Participate in development of the statistical analysis plan (SAP) for clinical studies and execute SAP throughout lifecycle of the study. - Perform data review and statistical analyses. Collaborate in writing statistical sections for integrated reports or and statistical reports. - Develop statistical programs as necessary to perform analyses and prepare data displays. - Participate in developing the case report form (CRF). - Participate in development of database clinical trial data specifications, including eCRF design, user requirements, edit rules checks, query logic, and data validations. - Comply with data integrity standards and business ethics requirements. - Keep abreast of new developments in statistics, industry development, and regulatory guidance through literature review and attendance at workshops and professional meetings. We offer you A unique opportunity to work in the field of medical technologies, where knowledge sharing and professional respect combine to make it both fun and meaningful to go to work. Both in Denmark and abroad you will meet enthusiastic colleagues who take pride in making a difference in a company whose products can truly impact other people s lives. We offer you freedom with responsibility , opportunities for training and career development, and a wide range of staff benefits. Application deadline Application deadline is Wednesday 19 June 2019. Start the application process by pressing Apply Online and follow the guidelines on our corporate career site or alternatively apply quick and simple through LinkedIn. Please attach your CV and other relevant documents. We look forward to receiving your application. For further information, please contact Director, Clinical Research, Fredrik Ceder at tel. 45 2760 4295. Qualifications We believe that you have a strong drive to be part of building the biostatics function in Radiometer and that you are motivated to join a team that is evolving, growing and influencing the business in new ways. This combined with the following increases your chances of success: - The qualified candidate has a Master s degree or PhD with at least 2 years experience within biostatistics from the life science industry - Strong knowledge of statistical theory, experimental design and clinical trial methodologies, linear and nonlinear modeling, categorical and non-parametric methods, sample size calculations - Must be highly-motivated, team-oriented, and organized with a strong attention to detail - Must have the ability to write documentation and understand, interact and communicate effectively in English. The following qualifications are an advantage:- Expertise in SAS. Solid knowledge of BASE SAS, SAS STAT, SAS MACROs, etc.- Familiarity with diagnostic clinical trial statistics - Familiarity with MDR, IVDR, FDA guidelines, and other regulatory requirements. Danaher Corporation Overview Danaher is a global science technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked 162 on the Fortune 500 and our stock has outperformed the S P 500 by more than 5,200 over 25 years. At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team. Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive. Organization: Radiometer Job Function: Science Primary Location: EMEA-Western Europe-Denmark-Hovedstaden-Brønshøj Schedule: Full-time

Description

You might be sitting with many ideas and a lot of motivation to drive the discipline of biostatistics. This is your chance to become our first internal Biostatistician that will contribute and advice on some of our most important development projects, influencing our strategy on how we obtain the most relevant medical claims. 

We are a leading provider of technologically advanced acute care solutions with more than 3,400 employees worldwide (1,100 in our Headquarters in Copenhagen/Brønshøj).

Welcome to Clinical & Medical Affairs in Radiometer’s R&D organization 

You report to Director of Clinical Research, Fredrik Ceder, who works closely with the Clinical Operations team and the Medical Affairs team to set the direction for the strategy of our clinical studies. Using your statistical and Life Science expertize you can expect to become a vital advisor for the team. Your many R&D-, Regulatory Affairs- and Marketing colleagues are also looking forward to working with you to develop our products in order to help caregivers even more in making diagnostic decisions that save lives.
We have a good pipeline of studies planned and we expect that you will be engaged in studies related to Immunoassay/Biochemistry, Cardiology and hematology to name some examples.  

Duties & Responsibilities:

- Provide statistical input to clinical team, study projects, and data management.
- Consult with project teams and apply statistical expertise to ensure scientific validity and proper design of studies, prepare written summaries for use by regulatory agencies and project teams.
- Provide statistical support to assist with sample size calculations and data analyses for clinical studies. 
- Participate in development of the statistical analysis plan (SAP) for clinical studies and execute SAP throughout lifecycle of the study.
- Perform data review and statistical analyses. Collaborate in writing statistical sections for integrated reports or/and statistical reports.
- Develop statistical programs as necessary to perform analyses and prepare data displays.
- Participate in developing the case report form (CRF).
- Participate in development of database clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic, and data validations.
- Comply with data integrity standards and business ethics requirements.
- Keep abreast of new developments in statistics, industry development, and regulatory guidance through literature review and attendance at workshops and professional meetings.  

We offer you

A unique opportunity to work in the field of medical technologies, where knowledge sharing and professional respect combine to make it both fun and meaningful to go to work. Both in Denmark and abroad you will meet enthusiastic colleagues who take pride in making a difference in a company whose products can truly impact other people's lives. We offer you 'freedom with responsibility', opportunities for training and career development, and a wide range of staff benefits.

Application deadline

Application deadline is Wednesday 19 June 2019. Start the application process by pressing "Apply Online" and follow the guidelines on our corporate career site or alternatively apply quick and simple through LinkedIn. Please attach your CV and other relevant documents. We look forward to receiving your application.
For further information, please contact Director, Clinical Research, Fredrik Ceder at tel. +45 2760 4295.
  

Qualifications 

We believe that you have a strong drive to be part of building the biostatics function in Radiometer and that you are motivated to join a team that is evolving, growing and influencing the business in new ways. This combined with the following increases your chances of success:
- The qualified candidate has a Master’s degree or PhD with at least 2 years' experience within biostatistics from the life science industry 
- Strong knowledge of statistical theory, experimental design and clinical trial methodologies, linear and nonlinear modeling, categorical and non-parametric methods, sample size calculations
- Must be highly-motivated, team-oriented, and organized with a strong attention to detail 
- Must have the ability to write documentation and understand, interact and communicate effectively in English.
The following qualifications are an advantage:- Expertise in SAS.  Solid knowledge of BASE SAS, SAS/STAT, SAS MACROs, etc.- Familiarity with diagnostic clinical trial statistics - Familiarity with MDR, IVDR, FDA guidelines, and other regulatory requirements.

 Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.

At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.

Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive. 

Organization:  Radiometer
Job Function:  Science
Primary Location:  EMEA-Western Europe-Denmark-Hovedstaden-Brønshøj
Schedule:  Full-time 

RADIOMETER MEDICAL ApSBrønshøj2019-06-07T00:00:002019-06-19T00:00:00
da-DK

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