- Supports successful implementation of new products and processes into the facility. - Assist with technology transfer from Process Development to manufacturing environment. - Plan, order and account for consumption of raw materials and components. - Prepare (wipe down) equipment and supplies for use in cleanroom environment. - Prepare and maintain reports and other documentation as applicable to the scope of operations in the manufacturing facility. Prepare and revise batch records and SOPs, as well as drafting of technical reports. - Coordinate sample testing and room release with QC. - Assist in the installation, maintenance, cleaning and operation of bioprocess equipment including chromatography systems, TFFsystems, centrifuges, analytical equipment and clean-in-place skids. - Ensures that standard operating procedures (SOPs) and batch records are accurate, and followed in accordance with cGMP regulatory expectations. - Conducts purification operations with an excellent understanding and knowledge of isolating and purifying proteins antibodies, etc. from microbial and cell culture processes. - Extensive experience with processes including cell disruption, operation and maintenance of tangential flow filtration devices, column packing and chromatography (HIC, IEX, Affinity), UF/DFoperations, and aseptic filtration, sampling for QC testing and storage of manufactured products. - Operate bioprocess equipment under strict adherence to cGMP, OSHA and required policies and regulations. - Recognizes and escalates bioprocess operational risks to team lead or Manager prior to failure, to ensure safety and compliance requirements. - Recommends and executes projects and changes to bioprocess operations to reduce risk and increase efficiency. - Performs in-process assays to monitor process performance. - Responsible basic trouble-shooting of technical issues and other problems encountered within the manufacturing process. Write deviation incident reports as needed. - Carry out the manufacturing review (as delegated) of the completed batch record logbooks in a timely manner per established targets. - Collaborate with the Quality Assurance group to fulfill quality management goals and ensure the highest quality manufacturing processes. Participates in QA training programs as required. - Identify areas for improvement in manufacturing efficiencies and compliance. - Assists with process, equipment, and cleaning validation initiatives. - Maintains gowning qualification as required. - Trains, coaches, and mentors manufacturing associates on downstream manufacturing functions, including compliance on all company/regulatory quality systems, safety procedures, and SOPs. - Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. - Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer - Has good interpersonal skills, is attentive and approachable. Discusses problems with colleagues and senior personnel. - Maintains a professional and productive relationship with supervisor and co-workers. - Ensure high standards of cGMP are adhered to at all times. - Occasionally provides support to other areas within the PBF such as fermentation or Fill/Finish activities.
- The person should be from science background with relevant Experience. - The position is required work in shifts. - Good interpersonal skills as the employee will be required to work in team oriented environment. - Attention to details. - Person should have faced or coordinated in Regulatory Audits. - The person should have good documentation practice.
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