BioSpace
Sr. Principal Scientist - TS/MS Device & Packaging
BioSpace, Indianapolis, Indiana, us, 46262
Overview
Sr. Principal Scientist - TS/MS Device & Packaging role at Lilly. This position supports the Device and Packaging Manufacturing division, providing technical oversight for new and existing medicines, supporting technical transfer, and optimizing control and capacity to maintain reliable supply. The role resides in Indianapolis, Indiana, with a focus on medical device design, manufacturing, labelling, and packaging processes. Join us to help deliver life-saving medications worldwide. This role emphasizes technical leadership in Technical Services/Manufacturing Sciences (TS/MS) and requires collaboration with regulatory functions, internal teams, and external partners to ensure compliance and continuous improvement. Responsibilities
Technical Subject Matter Expert (SME) Oversight : Demonstrate ownership for medical device design, manufacturing, labelling, and/or packaging processes. Liaise with regulatory to align on strategies for new products, packaging, platform changes, and consolidated technical change agendas. Stay current in risk management, technology, regulatory and compliance environments to improve design transfer and manufacturing processes. Prepare, review, and approve study designs, protocols, technical reports, and related documentation. Oversee qualification and validation strategy for device and packaging processes. Identify key engineering questions and develop solutions to advance business objectives. Innovation And Problem-Solving : Provide technical process support for production issue resolution with data analysis and first principles approaches. Identify and drive improvement opportunities and implement the organization’s technology transfer agenda. Support complex investigations and CAPA plans to prevent recurrence. Regulatory Compliance : Ensure adherence to regulatory requirements including cGMP, ISO 14971, ISO 11608, OSHA, and environmental sustainability goals. Support site inspection readiness and execution; interact with Regulatory Agencies during site inspections. Identify weaknesses and opportunities in control strategy and pursue improvements. Establish guidance and standards for critical aspects of operational and equipment control strategies for device and packaging platforms. Process Optimization : Develop local processes and procedures to enhance efficiency using lean tools. Apply first principles to define scientific approaches and improve material, process, automation, and product robustness, reducing variability and improving control strategies. Monitor critical parameters and drive continuous improvement. Cross Functional Collaboration : Foster knowledge sharing with internal and external partners to drive alignment and meet manufacturing goals. Integrate disciplines such as engineering and analytical science on technical projects and process improvements. Mentorship : Mentor and coach other technical resources on scientific and business approaches. Create a safe, inclusive environment for idea sharing and risk awareness in decision-making. Safety And Quality Culture : Lead by example in building a culture of safety and quality. Author, review, and approve GMP documentation including procedures, deviation investigations, change controls, regulatory submissions, validation protocols, and related documents. Minimum Qualifications
Bachelor’s degree in Science, Engineering, or related field. 5+ years of experience in pharmaceutical and/or medical device manufacturing or regulated industry. Strong understanding of cGMPs and regulated manufacturing. Ability to lead complex technical projects and make informed decisions. Additional Preferences
Prior experience in packaging and/or device assembling operations. Familiarity with commercialization processes and process control requirements. Strong technical leadership and communication skills across disciplines. Ability to work independently and in teams; collaboration across multiple disciplines. Analytical and problem-solving abilities; project management experience and basic statistical skills. Working knowledge of equipment and facility qualification processes. Ability to travel 0-50% as needed. Lilly is dedicated to helping individuals with disabilities to engage in the workforce. If you require accommodation to submit a resume, please complete the accommodation request form. Lilly is an EEO Employer and does not discriminate on protected characteristics. Our ERGs provide support networks for employees. Actual compensation varies by education, experience, skills, and location. Anticipated wage: $114,000 - $198,000. This role is full-time and eligible for a company bonus and comprehensive benefits package. #WeAreLilly
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Sr. Principal Scientist - TS/MS Device & Packaging role at Lilly. This position supports the Device and Packaging Manufacturing division, providing technical oversight for new and existing medicines, supporting technical transfer, and optimizing control and capacity to maintain reliable supply. The role resides in Indianapolis, Indiana, with a focus on medical device design, manufacturing, labelling, and packaging processes. Join us to help deliver life-saving medications worldwide. This role emphasizes technical leadership in Technical Services/Manufacturing Sciences (TS/MS) and requires collaboration with regulatory functions, internal teams, and external partners to ensure compliance and continuous improvement. Responsibilities
Technical Subject Matter Expert (SME) Oversight : Demonstrate ownership for medical device design, manufacturing, labelling, and/or packaging processes. Liaise with regulatory to align on strategies for new products, packaging, platform changes, and consolidated technical change agendas. Stay current in risk management, technology, regulatory and compliance environments to improve design transfer and manufacturing processes. Prepare, review, and approve study designs, protocols, technical reports, and related documentation. Oversee qualification and validation strategy for device and packaging processes. Identify key engineering questions and develop solutions to advance business objectives. Innovation And Problem-Solving : Provide technical process support for production issue resolution with data analysis and first principles approaches. Identify and drive improvement opportunities and implement the organization’s technology transfer agenda. Support complex investigations and CAPA plans to prevent recurrence. Regulatory Compliance : Ensure adherence to regulatory requirements including cGMP, ISO 14971, ISO 11608, OSHA, and environmental sustainability goals. Support site inspection readiness and execution; interact with Regulatory Agencies during site inspections. Identify weaknesses and opportunities in control strategy and pursue improvements. Establish guidance and standards for critical aspects of operational and equipment control strategies for device and packaging platforms. Process Optimization : Develop local processes and procedures to enhance efficiency using lean tools. Apply first principles to define scientific approaches and improve material, process, automation, and product robustness, reducing variability and improving control strategies. Monitor critical parameters and drive continuous improvement. Cross Functional Collaboration : Foster knowledge sharing with internal and external partners to drive alignment and meet manufacturing goals. Integrate disciplines such as engineering and analytical science on technical projects and process improvements. Mentorship : Mentor and coach other technical resources on scientific and business approaches. Create a safe, inclusive environment for idea sharing and risk awareness in decision-making. Safety And Quality Culture : Lead by example in building a culture of safety and quality. Author, review, and approve GMP documentation including procedures, deviation investigations, change controls, regulatory submissions, validation protocols, and related documents. Minimum Qualifications
Bachelor’s degree in Science, Engineering, or related field. 5+ years of experience in pharmaceutical and/or medical device manufacturing or regulated industry. Strong understanding of cGMPs and regulated manufacturing. Ability to lead complex technical projects and make informed decisions. Additional Preferences
Prior experience in packaging and/or device assembling operations. Familiarity with commercialization processes and process control requirements. Strong technical leadership and communication skills across disciplines. Ability to work independently and in teams; collaboration across multiple disciplines. Analytical and problem-solving abilities; project management experience and basic statistical skills. Working knowledge of equipment and facility qualification processes. Ability to travel 0-50% as needed. Lilly is dedicated to helping individuals with disabilities to engage in the workforce. If you require accommodation to submit a resume, please complete the accommodation request form. Lilly is an EEO Employer and does not discriminate on protected characteristics. Our ERGs provide support networks for employees. Actual compensation varies by education, experience, skills, and location. Anticipated wage: $114,000 - $198,000. This role is full-time and eligible for a company bonus and comprehensive benefits package. #WeAreLilly
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