Elanco
Technical Services Manufacturing Scientist (Night Shift)
At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose – to advance the health of animals, people, the planet and our enterprise. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Making animals’ lives better makes life better – join our team today! Your Role:
Technical Services Manufacturing Scientist (Night Shift) The Technical Services & Manufacturing Science (TS/MS) Scientist is responsible for providing Primary and/or Secondary loop technical support for commercial operations at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility. The position is a subject matter expert with respect to mAb products and processes and is engaged in tech transfer, scale-up, process optimization, validation, monitoring, troubleshooting and continuous improvement activities. The TSMS scientist plays a key role in day-to-day operations and delivery of technical projects. Your Responsibilities
Provide technical and on-floor support for the commercialization, manufacture, and life-cycle management of monoclonal antibody products. This includes troubleshooting, participate in product and process related technical investigations and root-cause analyses of process deviations, complaints, and OOS/OOE events. Act as product and process subject matter expert in Process Teams, project teams and committees. Use scientific and statistical analysis tools to improve process understanding, ensure manufacturing processes are capable and operating in a state of control, and identify opportunities for process improvements. Develop / execute projects to address process performance issues and deliver improvement opportunities. Author and provide critical review of technical documents including, but not limited to; batch records, SOPs, PFDs, risk assessments, investigations, technical studies, protocols, and reports. What You Need to Succeed (minimum qualifications)
Education: Bachelor’s degree (or equivalent experience) in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline. Experience: Experience in the Biotech / Pharmaceutical industry. Detailed understanding of biopharmaceutical production processes and technologies. Working knowledge of cGMP standards and experience working in a regulated environment. Proven analytical thinking and problem-solving skills. What will give you a competitive edge (preferred qualifications)
MSc or PhD in Bio/Pharmaceutical Technology, Microbiology, Engineering or a related discipline. Demonstrated experience in commercial monoclonal antibody / recombinant protein manufacturing processes. Experience in tech transfer, scale up, and validation of biopharmaceutical processes. Experience with SAP, JMP, Veeva Vault, RCI, FMEA and QRM tools. Working knowledge of USDA and/or EU GMP regulations for veterinary biologics. Additional Information
Location: Elwood, Kansas. Night shift position. Weekend work on a rotation to provide process support to ongoing operations. Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose – to advance the health of animals, people, the planet and our enterprise. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Making animals’ lives better makes life better – join our team today! Your Role:
Technical Services Manufacturing Scientist (Night Shift) The Technical Services & Manufacturing Science (TS/MS) Scientist is responsible for providing Primary and/or Secondary loop technical support for commercial operations at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility. The position is a subject matter expert with respect to mAb products and processes and is engaged in tech transfer, scale-up, process optimization, validation, monitoring, troubleshooting and continuous improvement activities. The TSMS scientist plays a key role in day-to-day operations and delivery of technical projects. Your Responsibilities
Provide technical and on-floor support for the commercialization, manufacture, and life-cycle management of monoclonal antibody products. This includes troubleshooting, participate in product and process related technical investigations and root-cause analyses of process deviations, complaints, and OOS/OOE events. Act as product and process subject matter expert in Process Teams, project teams and committees. Use scientific and statistical analysis tools to improve process understanding, ensure manufacturing processes are capable and operating in a state of control, and identify opportunities for process improvements. Develop / execute projects to address process performance issues and deliver improvement opportunities. Author and provide critical review of technical documents including, but not limited to; batch records, SOPs, PFDs, risk assessments, investigations, technical studies, protocols, and reports. What You Need to Succeed (minimum qualifications)
Education: Bachelor’s degree (or equivalent experience) in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline. Experience: Experience in the Biotech / Pharmaceutical industry. Detailed understanding of biopharmaceutical production processes and technologies. Working knowledge of cGMP standards and experience working in a regulated environment. Proven analytical thinking and problem-solving skills. What will give you a competitive edge (preferred qualifications)
MSc or PhD in Bio/Pharmaceutical Technology, Microbiology, Engineering or a related discipline. Demonstrated experience in commercial monoclonal antibody / recombinant protein manufacturing processes. Experience in tech transfer, scale up, and validation of biopharmaceutical processes. Experience with SAP, JMP, Veeva Vault, RCI, FMEA and QRM tools. Working knowledge of USDA and/or EU GMP regulations for veterinary biologics. Additional Information
Location: Elwood, Kansas. Night shift position. Weekend work on a rotation to provide process support to ongoing operations. Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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