What are the responsibilities and job description for the Labeling and Packaging Scientist - Advanced Therapies Manufacturing position at BioSpace?
At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
Lilly recently opened a cutting edge manufacturing facility dedicated to genetic medicines at Lebanon, Indiana. This facility is Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products. It includes next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission and start up the facility for both clinical and commercial supply. The TS/MS team will own all areas of technology transfer, process validation, and process stewardship.
Position Description
Labeling and Packaging Scientist – Technical Services/Manufacturing Scientist (TS/MS) role will initially support the delivery of the gene therapy drug product labeling and packaging operations, specifically regarding technical transfer and process validation internally and externally. Upon the start of commercial production, this role’s objectives include maintaining the validated state of applicable processes, establishing and monitoring metrics/methods to ensure a state of capability and control, harmonization of control strategies across process teams, evaluate process improvement, and serving as an escalation point for day-to-day operations issues. The principal role is a position that develops and implements a technical agenda and is responsible for providing technical leadership for the labeling and packaging processes at the LP2 site.
Key Objectives/Deliverables
Understand the scientific principles required for labeling and packaging of drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems.
Provide technical oversight for labeling and packaging materials.
Provide labeling and packaging technical support to operations with respect to materials, equipment, and processes.
Lead technical evaluations and specific problem resolution, including troubleshooting and root cause analysis.
Lead risk assessments of labeling and packaging operations and material suppliers.
Provide technical support for all start-up activities (e.g., tech transfer, process validation).
Provide technical support for non-routine (e.g., deviation, complaint) investigations, including consultation on quality and stability.
Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, APRs, etc.
Ensure that an accurate instruction set (tickets & procedures) describes the process as performed and the control strategy for the discrete manufacturing steps.
Support and/or own the technical agenda for the product or validation process.
Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability.
Serve as technical interface external to the LP2 site.
Provide audit support, as needed.
Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives.
Collaborate with and influence partners across global packaging sites and teams along a specific product supply chain.
Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities.
Basic Requirements
B.S. engineering, packaging science, or related field
3 years experience in a manufacturing organization focusing on labeling and packaging
Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
Additional Preferences
Pharmaceutical labeling and packaging manufacturing experience
Root cause investigation experience
Proven ability to work independently or as part of a team to resolve an issue.
Strong attention to detail.
Proficiency with computer systems including Microsoft Office products, Veeva Vault, electronic batch records, and SAP.
Knowledge and understanding of manufacturing processes
Strong interpersonal and teamwork skills
Strong self-management and organizational skills
Additional Information
Off-hours support may be needed, by request.
Required to respond, off shift, to operational issues.
Minimal travel required.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Lilly recently opened a cutting edge manufacturing facility dedicated to genetic medicines at Lebanon, Indiana. This facility is Lilly’s most technically advanced manufacturing site focused on the delivery of the next wave of innovative products. It includes next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and process performance. This is a unique opportunity to be a part of the team for the startup of a greenfield manufacturing site, and the successful candidate will help to design, commission and start up the facility for both clinical and commercial supply. The TS/MS team will own all areas of technology transfer, process validation, and process stewardship.
Position Description
Labeling and Packaging Scientist – Technical Services/Manufacturing Scientist (TS/MS) role will initially support the delivery of the gene therapy drug product labeling and packaging operations, specifically regarding technical transfer and process validation internally and externally. Upon the start of commercial production, this role’s objectives include maintaining the validated state of applicable processes, establishing and monitoring metrics/methods to ensure a state of capability and control, harmonization of control strategies across process teams, evaluate process improvement, and serving as an escalation point for day-to-day operations issues. The principal role is a position that develops and implements a technical agenda and is responsible for providing technical leadership for the labeling and packaging processes at the LP2 site.
Key Objectives/Deliverables
Understand the scientific principles required for labeling and packaging of drug products, including the interaction of the chemistry, equipment, aseptic processes, and container closure systems.
Provide technical oversight for labeling and packaging materials.
Provide labeling and packaging technical support to operations with respect to materials, equipment, and processes.
Lead technical evaluations and specific problem resolution, including troubleshooting and root cause analysis.
Lead risk assessments of labeling and packaging operations and material suppliers.
Provide technical support for all start-up activities (e.g., tech transfer, process validation).
Provide technical support for non-routine (e.g., deviation, complaint) investigations, including consultation on quality and stability.
Prepare, review, approve, and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, APRs, etc.
Ensure that an accurate instruction set (tickets & procedures) describes the process as performed and the control strategy for the discrete manufacturing steps.
Support and/or own the technical agenda for the product or validation process.
Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability.
Serve as technical interface external to the LP2 site.
Provide audit support, as needed.
Work within or lead cross-functional teams in a positive fashion to implement TS/MS objectives and deliver on business plan and quality objectives.
Collaborate with and influence partners across global packaging sites and teams along a specific product supply chain.
Ensure a safe working environment through compliance with safety rules and improve safety culture by actively participating in safety-related activities.
Basic Requirements
B.S. engineering, packaging science, or related field
3 years experience in a manufacturing organization focusing on labeling and packaging
Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
Additional Preferences
Pharmaceutical labeling and packaging manufacturing experience
Root cause investigation experience
Proven ability to work independently or as part of a team to resolve an issue.
Strong attention to detail.
Proficiency with computer systems including Microsoft Office products, Veeva Vault, electronic batch records, and SAP.
Knowledge and understanding of manufacturing processes
Strong interpersonal and teamwork skills
Strong self-management and organizational skills
Additional Information
Off-hours support may be needed, by request.
Required to respond, off shift, to operational issues.
Minimal travel required.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly