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Bioanalytical Scientist (f/m) - mass spectrometry, protein chemistry

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GlycoThera GmbH is a biotech company founded in 2001 and based in Hannover (Germany).  As a cGMP-certified company, we support a number of worldwide acting biopharmaceutical drugmakers in the development and the market authorization application of glycoprotein therapeutics (e.g. biosimilars).
In cooperation with our external (international) sponsors, we support the development of recombinant therapeutic proteins from bench-scale and large-scale production processes up to the release testing of the market products.
GlycoThera GmbH is authorized to perform quality testing of medicinal products for human use for upstream and downstream processes, drug substance and drug product release, process validation studies and stability studies. 
 
We would like to recruit at your earliest convenience a

Bioanalytical Scientist (f/m) with at least 3 years experience in the pharmaceutical / biotech industry
 
Excellent knowledge in the area of mass spectrometry, protein chemistry and HPLC-analytics of biopharmaceuticals is mandatory.

Job profile:
  • Timely planning and execution of analytical work packages (R&D, QC, stability/comparability testing) for biopharmaceutical products
  • Data evaluation and documentation according to internal procedures and GMP requirements
  • Responsibility for qualification/validation of mass spectrometric analytical procedures acc. to GMP regulations and ICH guidelines
  • Planning, supervision and execution of device qualification and software validation in the MS laboratory acc. to GMP regulations
  • Strong interaction with IT and Quality Assurance

Requirements:
  • Academic degree (M.Sc., PhD or equivalent) in medical or life sciences
  • Three years professional expertise in mass spectrometric analytics in a GMP-regulated environment, including device qualification and method validation
  • Multi-year experience in the area of quality control by mass spectrometric applications in a GMP environment
  • Knowledge in additional standard biopharmaceutical / protein analysis methods (e.g. SEC, IEX, HPLC, electrophoresis, CE)
  • Experience in analytical method development
  • Know-how in primary structural analysis of polypeptides
  • Good knowledge in current GMP regulations (EG-GMP, ICH, CFR, AMG, AMWHV)
  • Experience in project management and reporting experience would be beneficial
  • Excellent written and spoken English

Following a period of vocational adjustment, the applicant should be prepared to take a group leader position in conjunction with QA support.
 
We provide a multisided, challenging job position within a dedicated team. Based on your experience and knowledge, you will have the chance to actively influence and organize your field of activity. Moreover, you’ll have the opportunity to refine your expertise by contributing to cross-project questions in various areas of activities. Your participation in advanced internal and external training courses will be conducted and supported.



 

Kontaktdaten


Art des Bewerbungszugangs
Please send your informative application (inclusive curriculum vitae, desired salary and date of commencement) solely via e-mail with max. 3 pdf files attached to the following mailing address:

info@glycothera.de
 
GlycoThera GmbH
Feodor-Lynen-Straße 35
30625 Hannover
Ph:      ++49(0)511 978 1990 26 (secretariat)
Fax:     ++49(0)511 978 1990 28
 
Kontakt für Bewerbungen
see left side

Details der Stellenanzeige


Arbeitszeit
Vollzeit
Vertragslaufzeit
Festanstellung
Stellentyp
Fachkraft
Berufserfahrung
Berufserfahrung vorausgesetzt
Region
Deutschland (Niedersachsen)
Arbeitsort
30625 Hannover
Fachgebiet
Biologie & Life Sciences
JETZT BEWERBEN