USA
6 days ago
Clinical and Health - Scientist II, Manufacturing
Job Description: + Work in a team-based environment and perform antibodies purification for use in research and commercial scientific products for the life sciences industry. + Experiments are performed following controlled protocols and data is recorded on batch records following good documentation practices. Key Objectives of the role: + Responsible for manufacturing of product(s) in a lab setting following standard operating procedures. + Will utilize basic laboratory techniques, calculations, materials measurement, operation of laboratory equipment and record keeping necessary to manufacture products. + Will perform purification using AKTA, HPLC, and in process testing through SDS-Page. + Responsible for Batch Data Records, notebooks, customer reports and work order documents. + Utilize specialized technical knowledge and skills to make detailed observations and analyze data to ensure within operating parameters. + Advise manager of factors that may affect quality of product. + Suggest options/ideas for corrective actions. + Maintain equipment, product inventories and related records as assigned. + Note variances on manufacturing documents; audit and evaluate process documents and propose revisions. + Complete, distribute and file records as required in accordance with Document Control Practices. + Identify potential issues in the qualification process; report findings to team management and members for resolution or participate in troubleshooting. + May lead process improvement projects. + Complete, distribute and file records; prepare ad hoc reports as requested. + May perform other related duties as required and/or assigned. + Advise the team lead/manager of factors that may affect quality of the product, initiate problem reports for deviations and non-conforming materials, and suggest options and ideas for corrective actions and preventive actions (CAPA). Minimum Qualifications: + Bachelor's degree in Biology, Molecular Biology, Biochemistry, Biotechnology or other related discipline and 2+ years of experience in a manufacturing or research laboratory. + Plus: Masters. Degree in Biology, Molecular Biology, Biochemistry, Biotechnology or other related discipline and some experience in a manufacturing or research laboratory. + Experience in the use of scientific laboratory techniques, equipment and materials that includes some of the following techniques: AKTA purification of antibodies, SDS-page testing, HPLC analysis. + Ability to carry out scientific procedures and make recommendations for improvement. + Excellent documentation and communication skills. + Displays positive attitude toward job and others. + Regularly required to lift up to 20 pounds. + May be required to lift weight of 45 pounds or more, with assistance and/or with equipment on occasion. + Must be flexible to work varying schedules and hours as needed. + Must be able to work safely with chemicals and hazardous materials. + May be required to stand for long periods of time while performing duties. + May intermittently sit at desk/lab bench for a long period of time to perform experiments, write, and use a keyboard to communicate through written means. Preferred Qualifications: + Ability to work independently/in a group setting with direct supervision. + Works on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations. + Experience in ISO 90001, ISO 13485 and/or GMP manufacturing environment. Good problem-solving skills. + Expected first shift hours are Monday through Friday 8:00 AM - 4:00 PM excluding lunch time. + 1 teams interview Executing through Workorders. + Antibodies purification experience a big plus. Lab Setting experience critical. + Experience with Controlled guidelines.
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