Elanco
Fill/Finish Scientist- Technical Services Manufacturing Scientist
Elanco, Elwood, Kansas, us, 66024
Overview
Fill/Finish Scientist- Technical Services Manufacturing Scientist Join to apply for the
Fill/Finish Scientist- Technical Services Manufacturing Scientist
role at
Elanco . 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. Here, you’ll be part of a company that values and champions new ways of thinking, works with dynamic individuals, and offers opportunities to acquire new skills and experiences that will propel your career. Making animals’ lives better makes life better
– join our team today! Your Role
Your Role:
Fill/Finish Scientist- Technical Services Manufacturing Scientist The Technical Services & Manufacturing Science (TSMS) Scientist is responsible for providing primary and/or secondary loop technical support for commercial operations, specifically for primary and secondary packaging, 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, aseptic fill/finish, troubleshooting and continuous improvement activities. The TSMS scientist plays a key role in day-to-day operations and delivery of technical projects, relating to primary and secondary packaging. Responsibilities
Provide technical and on-floor support for commercialization, manufacture, media filling simulation, and life-cycle management of monoclonal antibody products. Provide on-floor support to the Manufacturing fill/finish teams regarding product and process troubleshooting, and support in resolution of technical and compliance issues. Prepare technical assessments and responses for site quality, internal inspection bodies, and relevant Health Authorities. Work with R&D, Manufacturing, and Quality teams in execution of technical / development studies, validation activities and technical transfer programs for fill/finish; participate in product and process related technical investigations and root-cause analyses of process deviations, complaints, and OOS/OOE events. Ensure issues are identified and captured in the relevant quality management system and that proper root cause analysis is performed with appropriate corrective and preventative actions. Assigned and ensure process operations comply with all health, safety, and environmental policies and procedures. Participate in Hazard and Operability (Haz-ops) studies and process safety reviews and identify / mitigate hazards of manufacturing processes and equipment. Act as product and aseptic filling 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; establish and deliver training / coaching on core processes and technologies to operational teams. 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; demonstrate strict adherence to local, state and federal requirements, cGMP standards and Elanco policies and procedures. Exemplify “Safety First and Quality Always” mind-set. Minimum Qualifications
Education: Bachelor’s degree (or equivalent experience) in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline. Experience: 3+ years’ experience in the Biotech / Pharmaceutical industry. Detailed understanding of biopharmaceutical fill/finish production processes and technologies, working knowledge of cGMP standards and experience in a regulated environment, strong analytical thinking and problem-solving skills, and proven ability to work in cross-functional teams with minimal supervision. Preferred Qualifications
MSc or PhD in Bio/Pharmaceutical Technology, Microbiology, Engineering or a related discipline. 5+ years’ experience in the Biotech / Pharmaceutical industry. Experience in commercial monoclonal antibody / recombinant protein manufacturing processes, with emphasis in primary and secondary packaging operations. Experience in tech transfer, aseptic media filling simulation, qualification, and validation of biopharmaceutical fill/finish line. Experience with SAP, JMP, Veeva Vault. Excellent technical writing skills. Understanding and application of RCI, FMEA and QRM tools. Working knowledge of USDA and/or EU GMP regulations for veterinary biologics. Additional Information
Travel: Minimal travel requirements Shift/Location: Day shift position with weekend (and potential evening work) on a rotation to provide process support to ongoing operations. Location: Elwood, Kansas EEO Statement and Benefits
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. Elanco Benefits and Perks: We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose. Highlights include: relocation packages, two weeklong shutdowns, 8-week parental leave, 9 Employee Resource Groups, annual bonus offering, flexible work arrangements, and 401K matching.
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Fill/Finish Scientist- Technical Services Manufacturing Scientist Join to apply for the
Fill/Finish Scientist- Technical Services Manufacturing Scientist
role at
Elanco . 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. Here, you’ll be part of a company that values and champions new ways of thinking, works with dynamic individuals, and offers opportunities to acquire new skills and experiences that will propel your career. Making animals’ lives better makes life better
– join our team today! Your Role
Your Role:
Fill/Finish Scientist- Technical Services Manufacturing Scientist The Technical Services & Manufacturing Science (TSMS) Scientist is responsible for providing primary and/or secondary loop technical support for commercial operations, specifically for primary and secondary packaging, 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, aseptic fill/finish, troubleshooting and continuous improvement activities. The TSMS scientist plays a key role in day-to-day operations and delivery of technical projects, relating to primary and secondary packaging. Responsibilities
Provide technical and on-floor support for commercialization, manufacture, media filling simulation, and life-cycle management of monoclonal antibody products. Provide on-floor support to the Manufacturing fill/finish teams regarding product and process troubleshooting, and support in resolution of technical and compliance issues. Prepare technical assessments and responses for site quality, internal inspection bodies, and relevant Health Authorities. Work with R&D, Manufacturing, and Quality teams in execution of technical / development studies, validation activities and technical transfer programs for fill/finish; participate in product and process related technical investigations and root-cause analyses of process deviations, complaints, and OOS/OOE events. Ensure issues are identified and captured in the relevant quality management system and that proper root cause analysis is performed with appropriate corrective and preventative actions. Assigned and ensure process operations comply with all health, safety, and environmental policies and procedures. Participate in Hazard and Operability (Haz-ops) studies and process safety reviews and identify / mitigate hazards of manufacturing processes and equipment. Act as product and aseptic filling 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; establish and deliver training / coaching on core processes and technologies to operational teams. 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; demonstrate strict adherence to local, state and federal requirements, cGMP standards and Elanco policies and procedures. Exemplify “Safety First and Quality Always” mind-set. Minimum Qualifications
Education: Bachelor’s degree (or equivalent experience) in Bio/Pharmaceutical Technology, Microbiology, Engineering, or a related discipline. Experience: 3+ years’ experience in the Biotech / Pharmaceutical industry. Detailed understanding of biopharmaceutical fill/finish production processes and technologies, working knowledge of cGMP standards and experience in a regulated environment, strong analytical thinking and problem-solving skills, and proven ability to work in cross-functional teams with minimal supervision. Preferred Qualifications
MSc or PhD in Bio/Pharmaceutical Technology, Microbiology, Engineering or a related discipline. 5+ years’ experience in the Biotech / Pharmaceutical industry. Experience in commercial monoclonal antibody / recombinant protein manufacturing processes, with emphasis in primary and secondary packaging operations. Experience in tech transfer, aseptic media filling simulation, qualification, and validation of biopharmaceutical fill/finish line. Experience with SAP, JMP, Veeva Vault. Excellent technical writing skills. Understanding and application of RCI, FMEA and QRM tools. Working knowledge of USDA and/or EU GMP regulations for veterinary biologics. Additional Information
Travel: Minimal travel requirements Shift/Location: Day shift position with weekend (and potential evening work) on a rotation to provide process support to ongoing operations. Location: Elwood, Kansas EEO Statement and Benefits
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. Elanco Benefits and Perks: We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose. Highlights include: relocation packages, two weeklong shutdowns, 8-week parental leave, 9 Employee Resource Groups, annual bonus offering, flexible work arrangements, and 401K matching.
#J-18808-Ljbffr