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 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 SOPs, 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, and SDS-page.Specific Responsibilities: Performs the assigned analytical tasks individually in support of 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 new analytical methods. Identifies technical challenges during analytical method development and performs method troubleshooting. Designs, follows, and reviews protocols, methods, and department procedures. Organizes and interprets scientific data. Documents analytical activities and results accurately in a timely manner and right first time. Communicates effectively with peers, supervisors, and management about the status of the assigned activities.Qualifications:Requirements and Personal Skills:Education: Graduation in chemistry, analytical chemistry, biology, biotechnology, biochemistry, pharmacy, or other related life science disciplines.Language: Good communication and interpersonal skills in English and Spanish, both written and verbal, are required.Experience: PhD/MS/BS with a minimum of 2 years of relevant experience in the 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-exclusion, ion-exchange, reverse and normal phase HPLC, iCIEF, CE-SDS, UV/Vis, ELISA, SDS-page, Western Blot, and other related protein characterization techniques.#J-18808-Ljbffr
