GMP Manufacturing and Process Development Manager
Xintela Ab Medicon Village / Kemiingenjörsjobb / Lund
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hela Sverige Visa alla jobb hos Xintela Ab Medicon Village i Lund Xintela is a biomedical company working in the field of regenerative medicine with first focus on treatment of osteoarthritis. For more information about the company, see
www.xintela.se. We are currently expanding and building our own GMP facility at Medicon Village in Lund for manufacturing of stem cell based advanced therapy medicinal products (ATMPs) for clinical trials. The cleanroom is currently being finalized and the qualification/validation of the facility and equipment, as well as the creation of the quality system, is ongoing.
We have a strong committed team which we now need to expand with a GMP Manufacturing and Process Development Manager. In this position you will be responsible for the manufacturing of mesenchymal stem cells for clinical trials and work in tight collaboration with the different product development functions in the company including R&D, QA and QC. As a member of a dynamic team in a small company you will have the opportunity to participate in both early R&D and in preparations for clinical trials, and you will have a strong influence on the activities performed.
In this role you will be responsible for the management of the cleanroom as well as working hands on with product development and manufacturing. This includes participation in a variety of activities such as maintenance of cleanroom procedures and SOPs; qualification/validation of equipment, manufacturing processes and analytical methods; performance of laboratory experiments; handling of materials and reagents; manufacturing of batches and reporting of data.
Main Responsibilities:
• Managing the cleanroom and cleanroom procedures
• Development and Implementation of the manufacturing processes
• Planning of manufacturing activities and manufacturing timelines.
• Manufacturing mesenchymal stem cells for clinical trials
Preferred Experience and Qualifications:
• BSc or MSc, or similar, in relevant field.
• Experience in pharmaceutical development, preferably within ATMPs
or biologics.
• Understanding of the translation from pre-clinical development to
clinical phase.
• Experience of cell culture techniques.
• Knowledge of GMP/QMS/SOPs/QC.
• Experience in cleanroom/aseptic techniques.
• Experience in the preparation of documents for regulatory
submissions (e.g. IMPD).
• Understanding of flow cytometry (FACS) analysis is advantageous.
• Business level written and spoken English.
• Strong interpersonal and networking skills.
• Strong computerized systems skills.
The person we are looking for should be problem solving, innovative, strategic minded and should thrive in a flexible work environment.
For questions or information regarding the position, please contact Liselotte Theorell (
liselotte@xintela.se) or Evy Lundgren-Åkerlund (
evy@xintela.se).
Send your application to Sara Baker
sara@xintela.se as soon as possible but no later than 2 May 2018. Applications will be reviewed continuously.
Publiceringsdatum2018-04-13Så ansöker duSista dag att ansöka är 0001-01-01
FöretagXINTELA AB MEDICON VILLAGE
AdressXINTELA AB MEDICON VILLAGE
22381 LUND
KontorsadressMedicon Village
Jobbnummer 4081270
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