WuXi Biologics
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Senior Scientist I, Quality Control
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WuXi Biologics Title: Senior Scientist I, QC Location: Cranbury, NJ WuXi Biologics
is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. WuXi Biologics’ achievements are a direct result of the efforts made by our employees. We have built an extraordinary team motivated by our PROUD culture of Passion, Reward, Opportunity, Unity, and Determination. WuXi Biologics offers exciting job opportunities and careers around the globe. We currently employ over 12,000 people and provide services to more than 600 customers worldwide, including all the top 20 biopharmaceutical companies. Responsibilities
Understand GMP and follow instructions on the documents. Perform micro, raw materials, compendia related testing including but not limited to bioburden, pH, growth promotion, endotoxin, conductivity, TOC, nitrate; execute lab procedures according to and in compliance with cGMP guidelines and internal SOPs. Receive required samples, perform testing, plate reading, plate transferring, report results independently and in a timely manner. Conduct EM/water/gas sampling in cleanroom areas in Cranbury or other US sites as needed. Support RM sample sampling and its transporting needs in Cranbury or other US sites as needed. Manage raw material, EM monitoring samples, sampling rooms, sample storage room and regulatory retain sample room, ensuring sampling and storage are conducted properly and within control. Support reagents/consumables inventory and invoices management to ensure QC Micro/RM/Compendia operation needs. Ensure all laboratory data comply with GDP practices to ensure data integrity. Ensure compliance with training, preparation, documentation and general lab maintenance requirements for Industry Standards and regulations. Generate documents such as SOPs, analytical methods, and On The Job training; train junior staff on methods. Optimize methods to improve efficiency while adhering to QC standards. Troubleshoot issues on assays, instruments, or reagents. Prepare or execute validation documents to support new materials, process changes and qualifications. Investigate any OOS/OOT and atypical results and laboratory investigations, perform root cause analysis, and implement CAPA. Attend internal and external meetings and present data summaries, investigation results, or trending analyses to project teams or clients. Respond to scheduled audits and defend methodologies to auditors. Any other duties assigned by the supervisor (when applicable). Qualifications
Full-time undergraduate degree or above, majoring in biology, chemical engineering, chemistry, pharmacy or related majors. Bachelor's degree: at least 9-11 years of experience in the professional field Master's degree: at least 7-9 years of experience in the professional field PhD: at least 2-4 years of experience in the professional field Extensive experience in micro assays, RM assays, analytical assays Ability to generate protocols and reports independently. Ability to follow GMP guidance and all QC general SOPs. Ability to draft SOPs or AMPs for operating equipment and performing analytical testing. Document and review experiments following GDP and ALCOA+ principles. Ability to perform and review data analysis/work independently. Ability to conduct basic troubleshooting. Ability to draft quality events, including lab investigations and deviations. Ability to complete work within predefined timelines; effective multi-tasking and time management are required. Able to draft EM trending reports independently. Able to provide suggestions to update and optimize AMPs/sampling plans accordingly. Ability to adapt between strategic and tactical thinking/planning and manage multiple priorities to achieve department and site objectives. Ability to understand technical data. Able to work on weekends when needed and support shift work. Basic experience in planning and ability to solve simple technical and operational problems. Able to raise issues immediately to supervisor and work with supervisor when in doubt. The job description does not intend to list all the duties and responsibilities assigned to this position. Employees holding this position would be required to perform other job-related duties as needed based on expertise and company business needs. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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Senior Scientist I, Quality Control
role at
WuXi Biologics Title: Senior Scientist I, QC Location: Cranbury, NJ WuXi Biologics
is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. WuXi Biologics’ achievements are a direct result of the efforts made by our employees. We have built an extraordinary team motivated by our PROUD culture of Passion, Reward, Opportunity, Unity, and Determination. WuXi Biologics offers exciting job opportunities and careers around the globe. We currently employ over 12,000 people and provide services to more than 600 customers worldwide, including all the top 20 biopharmaceutical companies. Responsibilities
Understand GMP and follow instructions on the documents. Perform micro, raw materials, compendia related testing including but not limited to bioburden, pH, growth promotion, endotoxin, conductivity, TOC, nitrate; execute lab procedures according to and in compliance with cGMP guidelines and internal SOPs. Receive required samples, perform testing, plate reading, plate transferring, report results independently and in a timely manner. Conduct EM/water/gas sampling in cleanroom areas in Cranbury or other US sites as needed. Support RM sample sampling and its transporting needs in Cranbury or other US sites as needed. Manage raw material, EM monitoring samples, sampling rooms, sample storage room and regulatory retain sample room, ensuring sampling and storage are conducted properly and within control. Support reagents/consumables inventory and invoices management to ensure QC Micro/RM/Compendia operation needs. Ensure all laboratory data comply with GDP practices to ensure data integrity. Ensure compliance with training, preparation, documentation and general lab maintenance requirements for Industry Standards and regulations. Generate documents such as SOPs, analytical methods, and On The Job training; train junior staff on methods. Optimize methods to improve efficiency while adhering to QC standards. Troubleshoot issues on assays, instruments, or reagents. Prepare or execute validation documents to support new materials, process changes and qualifications. Investigate any OOS/OOT and atypical results and laboratory investigations, perform root cause analysis, and implement CAPA. Attend internal and external meetings and present data summaries, investigation results, or trending analyses to project teams or clients. Respond to scheduled audits and defend methodologies to auditors. Any other duties assigned by the supervisor (when applicable). Qualifications
Full-time undergraduate degree or above, majoring in biology, chemical engineering, chemistry, pharmacy or related majors. Bachelor's degree: at least 9-11 years of experience in the professional field Master's degree: at least 7-9 years of experience in the professional field PhD: at least 2-4 years of experience in the professional field Extensive experience in micro assays, RM assays, analytical assays Ability to generate protocols and reports independently. Ability to follow GMP guidance and all QC general SOPs. Ability to draft SOPs or AMPs for operating equipment and performing analytical testing. Document and review experiments following GDP and ALCOA+ principles. Ability to perform and review data analysis/work independently. Ability to conduct basic troubleshooting. Ability to draft quality events, including lab investigations and deviations. Ability to complete work within predefined timelines; effective multi-tasking and time management are required. Able to draft EM trending reports independently. Able to provide suggestions to update and optimize AMPs/sampling plans accordingly. Ability to adapt between strategic and tactical thinking/planning and manage multiple priorities to achieve department and site objectives. Ability to understand technical data. Able to work on weekends when needed and support shift work. Basic experience in planning and ability to solve simple technical and operational problems. Able to raise issues immediately to supervisor and work with supervisor when in doubt. The job description does not intend to list all the duties and responsibilities assigned to this position. Employees holding this position would be required to perform other job-related duties as needed based on expertise and company business needs. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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