Manufacturing Associate 3 - Cell Culture-140004V4

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Description The Manufacturing Associate 3 operates process and ancillary equipment, in compliance with cGMP regulations, to support the production of OBI-1, a hemophilia therapeutic drug scheduled for commercial launch in 2014. The final title may differ and will be commiserate with experience and in alignment with our current internal team. Essential Duties and Responsibilities Functions in a leadership role for the assigned shift performing such tasks as: scheduling personnel to ensure task completion coverage of all required processes, communicating process and personnel issues to supervisor and acting in a supervisory capacity in the absence of supervisor Operate process equipment in upstream manufacturing performing processes such as: expansion of mammalian cells in roller bottles and flasks automated and manual cell culture systems supporting cell growth, expansion, and harvesting systems viral inactivation mixing systems Operate BSC’s, microscopes, incubators, mixing equipment, automated cell culture harvesting equipment, conductivity meters, autoclaves, and other manufacturing equipment Independently complete required documentation and guide other operators on proper GDP recording of entries and comments in batch records, forms and protocols Train less experienced or new staff on new procedures Author complex explicit documentation for new procedures as well as for current procedures Initiate Document change requests; author and revise manufacturing documentation Initiate and close deviations and CAPAs of moderate complexity and scope Initiate and close planned changes and change controls of moderate complexity and scope Perform real time Production Batch Record review prior to submission to supervisor Clean equipment and parts for use in cGMP operations using manual systems and Glassware washer. Prepare equipment and assemblies to be autoclaved. Qualifications Technical Knowledge Production/Processing - Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture of pharmaceutical products. Includes knowledge of aseptic technique and basic lab instruments, (Centrifuge, Pumps, Scales, etc.) Biology - Knowledge of organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment Safety/Security - Knowledge of relevant equipment, policies and procedures to promote effective and safe operations for the protection of people, data and company property Skills & Abilities Operation and Control - Controlling operations of equipment or systems Quality Control Analysis – Ensuring that products are evaluated for quality during the manufacturing process Mathematics - Using mathematics to solve problems (e.g. algebra) Problem Sensitivity - Ability to tell when something is wrong or is likely to go wrong. It does not involve solving the problem, only recognizing there is a problem Judgment/Decision Making - Considering the relative costs and benefits of potential actions to choose the most appropriate one Active Listening - Giving full attention to what other people are saying, taking time to understand directions provided or the points being made and asking questions as appropriate The following attributes are essential for this position Attention to Detail - being careful about detail and thorough in completing work Adaptability/Flexibility - being open to a considerable variety of schedules according to changes in production Schedule -This position will start out M-F in the interim, but will be going to a Wed-Sat schedule with (4 days, 10 hours) plus OT when necessary. Dependability - being reliable, responsible and fulfilling obligations especially in regards to working in a team environment and in a leadership as needed Education and Experience BS (or equivalent) in scientific discipline plus a minimum of five (5) years of related biological manufacturing experience in a CGMP environment Working Environment This is a position that will have a Wed-Sat schedule, 4 days, 10 hours Manufacturing environment with potential chemical, electrical and physical hazards. Personal protective equipment must be worn in the laboratories according to Baxter safety requirements. Possible exposure to cool/hot storage conditions. May be around moving equipment and machinery. May be working in a loud area that requires hearing protection and other protective equipment to be worn. May work around chemicals such as solvents, acids, bases and reactive or flammable materials. Inside working conditions. May require immunization before performing work within the manufacturing area. Will have interaction with other people. Pace may be fast and job completion demands may be high. Physical Demands May be required to stand for long periods of time while performing physical duties May be required to lift up to 30 lbs Must be able to work safely with materials and equipment
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