Sr. Principal Scientist - QA

Eli Lilly and Company • Us, IN

5d • Onsite

About The Position

The Sr. Principal Scientist - QA, is responsible for assuring and verifying QA responsibilities and expectations support for radioligand drug product manufacturing. The role provides Quality oversight during aseptic drug product manufacturing activities and performs final quality disposition of drug products for the Indianapolis Radioligand Therapies (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.
• 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-1 B, TN, 0-1, E-3, H-181, or L-1

Nice To Haves

• 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 with Manufacturing Execution Systems and electronic batch release.
• Excellent interpersonal, written and oral communication skills.
• 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.
• 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 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.

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: Principal