Scientist - TS/MS Parenteral - Visual Inspection

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.

Responsibilities

The Scientist – TSMS PAR will initially focus on the delivery of parenteral operations, specifically regarding technical transfer and process validation. TSMS PAR Scientists will support one of either formulation, filling, or visual inspection (VI), although may support multiple areas during start-up phase. 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
• Evaluating process improvement
• Serving as an escalation point for day-to-day operations issues
• Author and execute protocols as well as conduct root cause investigations

The principal role is a position that develops and implements a technical agenda and is responsible for providing technical leadership for the Parenteral Process Team. The principal role is expected to serve as a mentor within the TSMS team and engage in upstream and external to site activities related to parenteral manufacturing.

Key Objectives/Deliverables

• Support the assigned Process Team (formulation, filling, or VI) as TSMS representative (Associate/Senior)
• Serve as floor-level support and technical interface for manufacturing components, equipment, and operations for the TSMS team
• Represent Concord TSMS team for internal and external communications on a regular basis
• Lead risk management activities as it pertains to product/process
• Provide technical support to non-routine (e.g., deviation, complaint) investigations, including consultation on quality and stability issues
• Prepare and Review or approve, as required, relevant technical documents such as: Annual Product Reviews, Change Controls, Regulatory Submissions, Deviations, Validations, Procedures, PFDs, PFMEAs, etc.
• Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability
• Identify opportunities and lead technical projects to improve process control and/or productivity
• Serve as interface with upstream suppliers and parenteral product networks
• Drive stability strategy for Concord products
• Provide Audit support as needed
• Identify opportunities and participate in projects to improve process control and/or productivity

Requirements

• Bachelor's degree or higher in engineering, science, or related field
• 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.

Skills

• Pharmaceutical and/or medical device manufacturing experience
• Root Cause Investigation Experience
• Proficiency with computer systems including Microsoft Office products, Veeva Vault, TrackWise, electronic batch records, and SAP
• Demonstrated successful leadership of cross-functional teams
• Strong interpersonal and teamwork skills
• Strong self-management and organizational skills

Schedule

Role is Monday through Friday. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and/or off-hour work may be required.

Pay

The anticipated wage for this position is $66,000 - $171,600. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

Benefits

• Comprehensive benefit program including eligibility to participate in a company-sponsored 401(k) and 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)