Diese Stellenanzeige ist abgelaufen. Finden Sie hier zahlreiche ähnliche Jobs.

Bioanalytical Senior Scientist (f/m) with at least 5 years experience in the pharmaceutical / biotech industry

GlycoThera GmbH is a biotech company founded in 2001 and based in Hannover (Germany).  As a cGMP-certified company, we collaborate with a number of worldwide acting biopharmaceutical drugmakers in the development, quality improvement and the market authorization application (EMA/FDA) of glycoprotein therapeutics (e.g. innovative products and biosimilars).
In cooperation with our external (international) partners, 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 Senior Scientist (f/m) with at least 5 years experience in the pharmaceutical / biotech industry

Excellent knowledge in the area of mass spectrometry, protein chemistry and HPLC-analytics of biopharmaceuticals and profound long-term experience in MS method validation according to GMP regulations is mandatory.

Job profile:
  • Responsibility for qualification/validation of mass spectrometric analytical procedures acc. to GMP regulations and ICH guidelines
  • The candidate will hold  the position as Group Leader and will report to the Head of Mass Spectrometry / Protein Analysis and to the Head of QA
  • Research / collaboration planning, experimental design 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
  • 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
  • Presentation of research progress at meetings and communication to the head of MS department and clients
  • PhD in life sciences (biochemistry  preferred)
  • At least five years professional expertise in mass spectrometric analytics in a GMP regulated environment, including device qualification and GMP compatible method validation
  • Multi-year experience in the area of quality control by mass spectrometric applications in a GMP regulated environment
  • Excellent experimental skills and passion for analytical biochemistry / method development and leadership quality
  • Knowledge in  standard biopharmaceutical / protein analysis methods (e.g. SEC, IEX, RP-HPLC, CE) is mandatory
  • Excellent knowledge and experience in current GMP regulations (EG-GMP, ICH, CFR, AMG, AMWHV)
  • Proven project management skills, lead, manage and develop supervision of technical personal  and strong experience in scientific reporting
  • Excellent verbal and written communication skills (German / English)
  • You are known as a person for a high commitment and finding constructive solutions and  taking responsibility for your assignments
The applicant should 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 will 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.

How to apply:
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:

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
Bitte beziehen Sie sich bei Ihrer Bewerbung auf jobvector und geben Sie die folgende Referenznummer an: 20160317

Über GlycoThera GmbH

Entwicklung von rekombinanten Glycoprotein-Therapeutika aus tierischen Zellen, GMP-Analytik von rekombinanten Proteinen, Entwicklung von Diagnostika und Forschungsreagenzien

Mehr über die GlycoThera GmbH

Täglich neue Jobs per E-Mail erhalten