As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve t[ "\r\t. Responsible for all aspects of clinical man... more details
job summary: As the world's largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve t
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Responsible for all aspects of clinical manufacturing in the following areas: Cell Expansion, Cell Culture, Purification, Solution Preparation and Weigh/Dispense. Including freezing and put away products.
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Employee will move with the process and work seamlessly across all areas.
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Ensures all activities are performed to schedule.
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Manufactures products in various phases of product life cycles from clinical thru launch. Clearly understands, communicates, and manages differences in terms of documentation, sample handling, automation and cGMPs etc. for different phases of product life cycle.
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Provide feedbacks to handles and troubleshoots single use technology (SUT) from end to end in manufacturing process.
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Works cross functionally to ensure process is controlled and issues are escalated and investigated.
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Redlines and reviews controlled documents for various equipment/processes.
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Effectively employs all methods of communication (oral, written, presentation) to ensure knowledge and information transfer across shifts, to management, and cross functionally.
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Raises and supports investigation of deviations.
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Participates in safety investigations for CCTC and promotes safe behaviors at all times.
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BS in science related field is preferred
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MS or PhD in science related field with no prior industry experience
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Must have minimum of 2 years' experience.
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Transferable skills will be considered. or an equivalent combination of education and experience.
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Must be able to change shift schedule based on business and process needs.
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Must provide off-hour (night and weekend including holiday) coverage to meet business requirements on short notice.
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Ability to lift 45 lb.
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Preferences:
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Experienced with data integrity, regulatory, and cGMP requirements for pharmaceutical manufacturing.
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Experienced in operation of thermo SUM, 200L and 2000 bioreactors, Akta ready XL, Akta ready gradient, and Akta ready Flux XL.
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Experienced with business IT systems (Delta V, Team, outlooks, SAP etc.)
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Experienced with Microsoft Office. Excellent computer skills.
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Skill & Competency Requirements:
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Demonstrates strong tendency towards independent thinking and decision making.
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Able to make logical decisions independently for multiple process work streams with limited information or supervision available.
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Works with highest level of flexibility.
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Responds easily to last minute changes to production schedule.
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