Senior/Principal Scientist - Quality Operations

Lilly • Indianapolis, IN

1d • Onsite

About The Position

The Scientist -Quality Operations, is responsible for assuring and verifying QA responsibilities and expectations support for radioligand drug product manufacturing. The role provides Quality oversight as shift lead during aseptic drug product manufacturing activities and performs final quality disposition of drug product for the IRLT production site.

Requirements

• Bachelor's degree in science, engineering, computer, pharmaceutical related field of study or related technical degree.
• 5+ years of experience in QA/QC roles in the pharmaceutical industry.
• Mandatory Ability to work Wednesday - Saturday 10:00 am to 8:30 pm (Indianapolis, RLT Manufacturing Site (Onsite).
• 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 and 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

Nice To Haves

• This is a lead role requiring specific previous experience and is expected to be able to work independently when QA management is not present. The role provides manufacturing floor quality oversight, batch record review/disposition, inspection readiness, deviation/root cause investigations, change management, and cross functional team issue management.
• Ability to work independently and bring cross-functional team members together, and management as required, to manage potential failure modes, correct errors, remain organized and productive in a fast-paced joint team environment.
• Strong knowledge of Quality Management Systems and applicable regulatory requirements.
• Previous regulatory inspection readiness and inspection execution experience.
• Previous experience directly supporting large manufacturing and warehouse operation.
• Previous experience with Manufacturing Execution Systems and electronic batch release.
• Excellent interpersonal, written and oral communication skills.
• Strong technical aptitude and ability to train and mentor others.
• Ability to work overtime as required.
• Previous experience with SAP or other inventory management systems.
• Previous experience with deviation and change management systems.
• Previous experience with Lean, Six Sigma or other well-known improvement methodology.
• Previous experience working with radioligands preferred.

Responsibilities

• Support the site to ensure a safe work environment including supporting safety efforts for the QA Ops team.
• Provide quality support of IRLT with a focus on holistic involvement in key activities including real time review of batch records on the floor, coverage during media fill, providing first line of support for quality escalations associated with or impacting the manufacturing processes and Quality Control operations.
• Ensure that documented in-process checks have been completed for batch disposition including but not limited to deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release.
• Complete disposition of Drug product batches and Drug substance Intermediates.
• Ensure regular presence in operational areas (preparation, formulation, synthesis, filling and visual inspection, AQL, QC, warehouse etc. areas) as a part of QA on the Floor support to ensure facility is compliant with GMP and inspection ready. Record compliance and inspection readiness observations per established local and global procedures.
• Present QA floor observations quarterly driving cross‑functional visibility into trends, corrective actions, and opportunities for process optimization.
• Plan and schedule tasks qualification and requalification activities. Provide training to floor QA and batch QA personnel as SME and qualified trainer for batch and floor QA tasks qualifications. Oversee execution of the same activities after training completion to provide feedback for sustaining compliance and development of the QA Ops organization.
• Provide technical/quality review of documentation that supports manufacturing (e.g., deviations, changes, procedures, protocols, training documents, analytical method validations), as applicable.
• Support the development of the overall site operational readiness plan including development of quality processes and approval of operational procedures.
• Drive operational excellence in floor operations and disposition process through data analysis to reduce variability and shift performance cycle times to align with supply delivery targets.
• Work cross-functionally with the area process teams for metrics reviews (e.g. deviation closure times, batch record release times, training completion etc.) to enhance operational support, and issue / deviation management.
• Assess and triage deviations that occur on shift in collaboration with the site process team.
• Lead, mentor, and coach operations and support personnel as quality SME during troubleshooting activities for manufacturing and QC operations.
• Perform any additional duties as required to support the business.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior