Quality Control Bioassays Specialist

Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion. Together we develop medicines, offering new hope to patients suffering from serious diseases.

We create a passionate and friendly workplace environment. Join us! www.polpharmabiologics.com

We are looking for:

Quality Control Bioassays Specialist

 

You will take care of:

  • Performing quality control testing at every production stage as well as Drug Substance and Drug Product release and stability testing and results processing and interpretation. Verification of other analysts’ results
  • Collection and registration of samples, raw materials, semi-finished products, finished products for analytical and microbiological tests (if required). Sample management
  • Planning and performing analytical methods validation including preparing all related documentation
  • Analytical methods results and transfer and validation documentation verification and review according to approved procedures
  • Creating (with supervisor consultation) Standard Operating Procedures, Instructions and Analytical Methods and conducting trainings on them
  • Close cooperation and communication with other Polpharma Biologics teams
  • Performing maintenance, calibration and qualification of laboratory equipment according to instructions and procedures
  • Supervising work of technicians in the assigned tasks
  • Performing common laboratory tasks i.e.: reagents preparation, waste management (including hazardous waste), reagents and materials management and re-ordering
  • Collection of quotations from vendors and placing orders including preparing all related documentation (under supervision)
  • Participation in trainings (scheduled by supervisor) and training other analysts

 

If you have:

  • 5 years of experience in GMP production environment with direct involvement in USP of microbial process
  • Extensive knowledge of microbial cultivation and primary recovery processes, as well as of scale-up/scale-down techniques
  • Knowledge of cGMP regulations
  • Experience with GMP inspection, FDA inspection will be an asset
  • Experience with stainless steel technology in production
  • Experience with CIP of production equipment
  • Knowledge and understanding of process, equipment and systems to troubleshoot problems and provide solutions
  • Ability to work efficiently under time pressure with multiple tasks simultaneously to meet timelines and goals
  • Fluency in English, knowledge of the Polish language will be of advantage
  • Strong leadership and people development skills combined with good communication skills
  • Good learner with flexible attitude to work
  • Bachelor’s, Master’s or PhD degree  in Biotechnology, Biochemistry, Life Technologies or related field)

Join our Team!

 

We offer:

  • Sport card
  • Development programs
  • Private healthcare
  • Relocation package
  • Fruit day
  • Integration events
  • Benefit platform
  • and more
Poznaj pracodawcę  
Polpharma Biologics S.A.
 

Polpharma Biologics S.A.

Quality Control Bioassays Specialist

 
Miejsce pracy: Polska, Pomorskie, Gdańsk
 
Umowa o pracę
   
Ważna jeszcze 34 dni (do 2019-09-21)
 
 

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