Master Associate, Manufacturing Purification Operations Description:This position will be responsible to execute complex unit operations in Purification for clinical and commercial production of biopharmaceuticals in a multi-product facility. The position will include creating appropriate and accurate manufacturing batch records and standard operating procedures based on the large scale process description. The Master Associate will participate in detailed facility fits prior to the start of a new product introduction or clinical re-supply campaign, troubleshooting exercises and continuous improvement projects.You will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect our high regard for our employees.Duties & Responsibilities:Responsible for CIP/SIP, product change over, and daily execution of manufacturing activities for Purification in large scale clinical and commercial manufacturing.Must have a strong understanding of new product introduction and multiproduct operations. Support troubleshooting efforts for Purification steps.Support Bill of Material (BOM) creation, data gathering, and training of new equipment and processes.Must be able to collect, interpret and give data based suggestions for process and product improvement.Must be familiar with LEAN and six sigma manufacturing methodologies.Monitors and controls purification steps in clinical as well as in commercial processes.Identify and report any issues related to manufacturing performance, process and safety to appropriate project teams. Train junior staff on purification related operational units. All training will be conducted with an emphasis on safety and completion of operations in a timely manner.Collaborates within team and department in order to follow best practices and meet department goals.Report any issues related to manufacturing performance, process and safety to the manager in order to ensure safety, compliance with regulations and cGMPs and to facilitate continuous process improvement.Requirements:Bachelors’ Degree, from an accredited university, with a minimum of four (4) years of professional industry experience OR a High School Diploma/GED and a minimum of eight (8) years of professional training/industry experience or equivalent.Experience working in large scale Purification operations under cGMP conditions.Possess effective troubleshooting skills with equipment and/or process.Desired Experience, Skills and Abilities:Requires strong problem-solving and troubleshooting skills as demonstrated by a consistent track record of solutions to technical problems within large scale cGMP Purification Manufacturing.Ideally candidates should possess knowledge in the following: CIP, SIP, SOP, cGMP, GDP, TFF/ Tangential Flow Filtration, UF/DF, Chromatography columns, Column packing, Buffer Prep, Solution Prep, Buffer Chemistry, pH, Conductivity, A280 Spectrophotometry, Kaizen, Lean, 5S, Green Belt, Delta V, Troubleshooting, Virus filtration, Depth Filtration, Bulk Filtration, Aseptic technique, Validation, Clinical, Commercial, Commissioning, IQ, OQ, MabSelect, Protein-A, antibody/Antibodies, Monoclonal, Autoclave, Filter integrity testing.Eligibility Requirements: Must be legally authorized to work in the United States without restriction.Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational backgroundMust be willing to take a drug test and post-offer physical (if required)Must be 18 years of age or older
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