About the position
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview: Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN (Lilly Lebanon API). This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.
Responsibilities
- Provides technical oversight and stewardship for one or more molecules manufactured at Lebanon facility.
- Leads the technical transfer of processes from one production facility to another, anticipating and addressing complex scale-up issues.
- Provides mentorship and scientific expertise to Process Team members monitoring, trending, and analyzing production data.
- Applies process knowledge and data analysis skills to support the management of daily manufacturing operations.
- Presents process data and analyses with Process Team members at Manufacturing Process Team meetings.
- Drives solutions impacting results across sites or function.
- Authors technical reports supporting process control strategies, technology transfers, process validation, deviation/adverse event reporting, process monitoring/analyses, and technical studies.
- Reviews/approves Annual Product Review and presents annual Global Product Assessment for stewarded molecule(s).
- Leads resolution of technical issues including those related to control strategy and manufacturing.
- Troubleshoots issues in conjunction with Process Teams and/or manufacturing staff on the manufacturing floor.
- Anticipates and resolves key technical or operational problems that impact function or geography.
- Communicates issues in a timely manner.
- May lead process-related investigations and assess technical impact.
- Influences complex regulatory or technical issues within the TS/MS area/function.
- Writes standard operating procedures as they relate to the activities of the TS/MS group.
- Reviews and approves manufacturing batch records and other manufacturing documentation.
- Works with Process Team members to ensure successful process knowledge transfer to the Manufacturing staff on the manufacturing floor.
- Assists in process-related training of Manufacturing Process Team members.
- Designs laboratory experiments in support of process troubleshooting and/or continuous improvement.
- Helps to define and implement medium to large continuous improvements to manufacturing processes.
- Works with Manufacturing to support the start-up and validation of new facilities and the associated process equipment.
- Helps to define and implement control strategies for Lilly Lebanon processes.
- Leads post launch technical agendas and delivers projects that drive substantial step changes in Manufacturing.
- May lead, or assist in the planning and execution of process validation activities.
- May own, or assist in the implementation of medium to large process-related change controls with greater risk, resource / financial requirements, or complexity.
- Makes decisions that impact a function or geography.
- Builds relationships with internal and external partners.
- Understands, and performs all job responsibilities in compliance with, safety and regulatory expectations as well as cGMP.
Requirements
- Masters or PhD in science or engineering field (PhD preferred).
- 10+ years of experience in a cGMP small molecule/API manufacturing.
- Process and equipment knowledge of active pharmaceutical ingredients.
- Thorough understanding of GMP requirements for a large-scale manufacturing facility.
Nice-to-haves
- Demonstrated leadership skills.
- Process validation, cleaning validation, and commercialization experience a plus.
- Excellent communication skills, both oral and written.
Benefits
- 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.
- Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).
