Overview:
From Algenex a company specialized in the development and manufacture of recombinant proteins for the formulation of biological medicines, we are incorporating an Analytical development technician for our site in Tres cantos, Madrid.
General Responsibilities:
The Analytical Development Technician will be responsible for:
- The development, qualification and validation of the new analytical methods.
- Sample testing to support process and formulation development and other development activities of the products at all stages of development.
- Support in Drafting of SOP, methods, Validation protocols and reports.
- Support in the management of reagents, standards and samples.
- The analytical techniques include, but are not limited to Size-exclusion, Ion Exchange, reverse phase and normal phase HPLC, ELISA, cIEF, CE-SDS, Western Blot, SDS-page.
Responsibilities:
Specific Responsibilities:
Performs the assigned analytical tasks individually in support of the product development, registration, lot release, pre and post regulatory submission activities.
Performs activities within the assigned timelines and in compliance with cGXP'S, regulatory requirements and company practices and procedures.
Development, qualification and validation of the new analytical methods. Identifies technical challenges during analytical method development and perform method trouble shooting.
Designs, follows and reviews protocols, methods and department procedures.
Organizes and interpretates scientific data.
Documents analytical activities and results accurately in timely manner and right first time.
Communicates effectively with peers, supervisor and management about the status of the assigned activities.
Qualifications:
Requirements and personal Skills:
Education: Graduation gained from chemistry, analytical chemistry, biology, biotechnology, biochemistry, pharmacy or other related life science disciplines.
Language: Good Commucation and interpersonal skills in English and Spanish both written and verbal are required.
Experience (year/area): PhD/MS/BS with minimum of 2 years of relevant experience in biopharmaceutical/biotechnology industry in the Analytical Development, Analytical Validation or Quality Control area.
Specific Knowledge:
Knowledge of biologics and industry experience in biologics products. Experience with peptides and proteins.
Hands-on experience in analytical methods such as size-exclution, ion-exchange rever and normal phase HPLC, iCIEF, CE-SDS, UV/Vis, ELISA, SDS-page, western blot and other related protein characterization techniques.
