Quality Control Scientist I

At mAbxience, a company specialized in the development and manufacturing of biosimilar medicines, we are hiring a Bioassay Scientist for our Manufacturing Site in León (Spain).La experiencia que se espera de los solicitantes, así como las habilidades y cualificaciones adicionales necesarias para este trabajo, se enumeran a continuación.GLOBAL RESPONSIBILITYThis individual will be responsible to co-ordinate the work of the Bioassay group inside analytical development. The main task will be development, qualification and validation of new bioanalytical methods, co-ordination of sample testing to support process and formulation development and other developments activities of biotherapeutics drug candidates at all stages of development. Review of external development and qualification & validation reports. Bioanalytical techniques include but are not limited to high complexity cell based test assays(ADCC, CDC, neutralization, apoptosis, etc.), SPR, target binding ELISA, Flow Cytometer based binding assays as well residual impurities analysis in compliance with GLP/GMP and regulatory guidance as it relate to drug substance and drug product development. This individual will be required to present and interpret scientific data, write technical reports, and represent the team in matrix team or R&D group meetings when needed.SPECIFIC RESPONSIBILITIESPerforms the assigned analytical tasks individually if needed in support of productdevelopment, registration lot release, pre and post regulatory submissionactivities. Performs activities within the assigned timelines and in compliance withGLP/GMP, regulatory requirements and company practices and procedures.-Co-ordinate and supervise the work of the Bioassay group (Technicians and Analysts).-Develop, implement, and qualify high complexity Surface Plasmon Resonance (SPR), cell-based test assays (ADCC, CDC, neutralization, apoptosis etc.) as well in process impurities in compliance with GLP/GMP and regulatory guidance to support process and formulation developmentwith minimum supervision.-Identifies technical challenges during analytical method development and perform method trouble shooting.-Proactively participates in activities in support of process development and process changes-Designs, follows, and reviews protocols, scientific methods, and departmentalprocedures; Organizes and interprets scientific data.-Documents analytical activities and results accurately, in a timely manner and right-first time.-Reviews and checks analytical data generated by peers and maintains integrityof data.-Communicates effectively with peers, supervisor, and management about the status of the assigned activities, maintaining supervisor constantly updated.-Write and review technical and data analysis reports, SOPs, Tech Transfer documents and maintain accurate, precise, legible documentations.-Supporting quality control during tech transfer and Validation.REQUIREMENTS AND PERSONAL SKILLSEducation: Master’s degree or PhD with major in BiologicalSciences or another science-related major. Languages: Excellent communication and interpersonal skills in English and Spanish, both written and verbal are required. (Spanish is not a must). Experience (years/area):o PhD with 5-year industry experience or MS with minimum 8-10 year ofrelevant experience in biopharmaceutical/biotechnology industry. Graduationgained from chemistry, analytical chemistry, biology, biochemistry, immunology,bioengineering, Pharmacology, or other related disciplines preferred.o Min of 5-7 years’ experience with development, validation of bioanalytical assaymethods in a regulated Good Laboratory Practices (GLP) and/or GoodManufacturing Practices (GMP) environment.o Hands-on experience and proficiency with the use of various bioanalytical andbiochemical tools including but not limited to SPR, ELISA, Western blot,enzymatic assays, cell-based assays.o Hands-on experience with Flow Cytometry. Specific Knowledge:o Knowledge of Surface Plasmon Resonance (SPR) platform. xcskxlj o Knowledge of biologics and industry experience in biologics research /developmentMabxience is a company committed to equal opportunities, and therefore, all candidates will be considered without distinction of race, color, gender, age, sexual orientation, religion, origin, marital status, citizenship, or disability.