Associate Director TSMS
Eli Lilly and Company
4 hours ago
On-site
Indianapolis, IN
Operations
Responsibilities:
- Ensure technical review and approval for documents (investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies).
- Hire, manage, mentor, and develop a team of scientists and technical staff; foster excellence, accountability, and continuous learning.
- Partner within TSMS and across functions to implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives.
- Interact with regulators/customers/stakeholders and support internal/external agency audits.
- Provide oversight and technical excellence for investigations and complaints; oversee technical projects to improve process control, capacity, yield, and quality.
- Represent and engage in site/network governance meetings to influence technical agendas.
- Network globally to share best practices and control strategies to harmonize/alignment across sites.
- Engage Pharmaceutical Product Development for applicable technical transfer deliverables for new molecule entities during commercialization stages.
- Champion data analytics, statistical process control (SPC), and real-time monitoring to improve performance and reduce variability.
- Define and implement a site digitalization roadmap with Digital/IT and Engineering.
- Drive digitalization initiatives (MES, digital execution, data historians, advanced analytics dashboards).
Basic Qualifications:
- B.S., M.S., or Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related STEM discipline.
- 6+ years (B.S./M.S.) or 5+ years (Ph.D.) relevant cGMP commercial API manufacturing experience in TSMS or related disciplines (Manufacturing, QA, QC, Engineering, Regulatory Sciences).
Preferred Qualifications/Skills:
- Maintain a safe work environment.
- Ability to influence and lead diverse groups; influence complex regulatory/business/technical issues.
- Hands-on digitalization experience (MES, data historians e.g., OSIsoft PI, digital execution, LIMS).
- Track record leading/contributing to continuous improvement using digital tools and analytics.
- Technical leadership; administrative/organizational skills; strong internal/external relationship building.
- Ability to deliver highly complex, cross-functional work; strong project management; analytical/problem-solving skills.
- Communicate and influence across stakeholders; strategic thinking and flexibility.
Additional Information (role requirements):
- Minimal travel (<10%); some off-shift work (nights/weekends) may be required to support 24/7 operations.
Benefits (as stated):
- Eligible for company bonus; comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits (EAP, fitness, clubs/activities).
- Ensure technical review and approval for documents (investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies).
- Hire, manage, mentor, and develop a team of scientists and technical staff; foster excellence, accountability, and continuous learning.
- Partner within TSMS and across functions to implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives.
- Interact with regulators/customers/stakeholders and support internal/external agency audits.
- Provide oversight and technical excellence for investigations and complaints; oversee technical projects to improve process control, capacity, yield, and quality.
- Represent and engage in site/network governance meetings to influence technical agendas.
- Network globally to share best practices and control strategies to harmonize/alignment across sites.
- Engage Pharmaceutical Product Development for applicable technical transfer deliverables for new molecule entities during commercialization stages.
- Champion data analytics, statistical process control (SPC), and real-time monitoring to improve performance and reduce variability.
- Define and implement a site digitalization roadmap with Digital/IT and Engineering.
- Drive digitalization initiatives (MES, digital execution, data historians, advanced analytics dashboards).
Basic Qualifications:
- B.S., M.S., or Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related STEM discipline.
- 6+ years (B.S./M.S.) or 5+ years (Ph.D.) relevant cGMP commercial API manufacturing experience in TSMS or related disciplines (Manufacturing, QA, QC, Engineering, Regulatory Sciences).
Preferred Qualifications/Skills:
- Maintain a safe work environment.
- Ability to influence and lead diverse groups; influence complex regulatory/business/technical issues.
- Hands-on digitalization experience (MES, data historians e.g., OSIsoft PI, digital execution, LIMS).
- Track record leading/contributing to continuous improvement using digital tools and analytics.
- Technical leadership; administrative/organizational skills; strong internal/external relationship building.
- Ability to deliver highly complex, cross-functional work; strong project management; analytical/problem-solving skills.
- Communicate and influence across stakeholders; strategic thinking and flexibility.
Additional Information (role requirements):
- Minimal travel (<10%); some off-shift work (nights/weekends) may be required to support 24/7 operations.
Benefits (as stated):
- Eligible for company bonus; comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits (EAP, fitness, clubs/activities).