Principal Scientist - Visual Inspection

About the role

The IPM Visual Inspection Steward is a technical position that develops and implements a technical agenda. Primary objectives include reliable and compliant manufacturing of the parenteral products and improvement of the process control strategy focusing on the visual inspection process. The TS/MS Visual Inspection Steward role will report directly to the IPM Syringe Plant TS/MS Senior Director and will be responsible for driving the tech agenda and mentoring the technical staff.

Responsibilities

• Own a technical agenda for syringe visual inspection platform, including Manual, Semi-Automatic, and Automatic inspection, including continuous improvement, compliance initiatives, process control, yield, and/or productivity.
• Serve as a technical mentor for Scientists, leaders, and other disciplines. Provide technical guidance to the TS/MS group.
• Provide technical support to non-routine (e.g., deviation, process removal) investigations, including consultation on quality issues, resort recommendations, and process changes.
• Prepare, Review and Approve, as required, relevant technical documents, such as: Change Controls, Deviations, Procedures, etc.
• Support identification and development of new inspection technologies and/or techniques. Subsequent implementation for the improvement of existing commercial manufacturing processes.
• Understand and influence the manufacturing control strategy for the various operational areas.
• Drive control, capability, productivity, and continuous improvement for the process.
• Network and collaborate with global and other parenteral sites to understand best practices and share knowledge.
• Support site inspection readiness and execution. This role may have direct interaction with Regulatory Agencies during site inspections.

Basic Requirements

• Bachelor's Degree in scientific disciplines of Material Science, Chemistry, Biology, Pharmacy, Engineering, or equivalent.
• 3+ years of pharmaceutical manufacturing experience in TS/MS or associated disciplines such as Manufacturing, Quality Control, Quality Assurance, or Engineering.
• 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.

Qualifications

• Strong technical aptitude and ability to train and mentor others
• Proven Teamwork and interpersonal skills
• Problem solving and independent decision-making skills
• Oral and written communication skills that demonstrate an ability to effectively (e.g., clearly, succinctly) communicate with all levels of the organization.
• Ability to influence diverse groups
• Previous experience with deviation and change management systems
• Previous experience with regulatory agencies during site inspections
• Previous experience with visual inspection or defect classification – components incoming inspection and/or drug product inspection

Pay

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $102,000 - $171,600. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

Benefits

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).