Associate Engineer, Process Engineering, (m/f)
Posted on Jan 19, 2019 by Juno Therapeutics GmbH
Manufacturing & Operations, Munich, Germany
Juno Therapeutics, a Celgene Company, is developing novel cellular immunotherapies based on two distinct and complementary platforms - Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body's immune system to treat cancer. For our Process Engineering Team located in Munich, we are looking for an Associate Engineer . Activities and responsibilities PRIMARY RESPONSIBILITIES:
• Process development, optimization and scale up of biotechnological processes (USP and DSP) to produce proteins for our reagents
• Development of GMP- conform production processes and facilitate the transfer from Technical Development at lab scale to GMP manufacturing
• Planning and execution of biotechnological and biochemical experiments that involve profound knowledge of protein biological techniques
• Authoring of process relevant documentation for GMP production (Forms, Master Batch Records, SOPs)
• Ability to increase knowledge about biopharmaceutical manufacturing processes by self-learning in literature and other sources, e.g. microbial fermentation, bioreactor use, protein refolding, depth filtration, tangential flow filtration, column chromatography, centrifugation, and formulation of bulk drug substance
• Support of our production team in performing cGMP manufacturing activities according to standard operating procedures (SOPs) and batch records in accordance with assigned daily tasks and production schedule.
• Experience with Quality Systems (Deviations, CAPAs, Change Control, etc.) would be beneficial, but not mandatory
• Identification, implementation, and qualification of new devices. Assistance in validation of procedures in our production facility
• Expertise in documentation and presentation of results, compilation of development reports
• Training of (new) staff on processes and process relevant devices Qualification profile REQUIRED QUALIFICATIONS:
• Experience/Background in bioprocess engineering, preferably with hands on experience (e.g. in Crossflow Filtration, Depth Filtration and Fermentation)
• Knowledge in biotechnology and development of bioprocess procedures
• Networking and communication skills
• Dedicated team player
• Ability to work in a fast developing environment, according to set priorities and timelines
• A Masters degree (or comparable) preferentially in biotechnology/ bioprocess engineering favorably with 1+ years of relevant experience in a GxP regulated environment. Benefits Juno Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, age, sex, sexual orientation, gender identity or gender expression, national origin, citizenship, disability, genetic information, veteran status or military status, or any other classification protected by applicable law. Juno complies with all applicable national, state/provincial, and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements. All applicants must have authorization to work for Juno Therapeutics in the country in which the position is based.
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