Summary

The API & Drug Substance Operations Supervisor leads the day-to-day execution and continual improvement of manufacturing operations in a highly regulated environment, owning process performance and escalation pathways across API production. This role centers on maintaining safe, compliant operations by monitoring process alarms and responding to adverse events per established procedures, while serving as the expert consult for novel or unprecedented manufacturing challenges. It requires diagnosing and troubleshooting both routine and complex issues to restore and sustain production, with a focus on quality, compliance, and proactive problem solving. The Supervisor also guides teams in applying production management best practices to minimize recurrence and protect the integrity of the manufacturing process.

Job description

Summary

The API & Drug Substance Operations Supervisor leads the day-to-day execution and continual improvement of manufacturing operations in a highly regulated environment, owning process performance and escalation pathways across API production. This role centers on maintaining safe, compliant operations by monitoring process alarms and responding to adverse events per established procedures, while serving as the expert consult for novel or unprecedented manufacturing challenges. It requires diagnosing and troubleshooting both routine and complex issues to restore and sustain production, with a focus on quality, compliance, and proactive problem solving. The Supervisor also guides teams in applying production management best practices to minimize recurrence and protect the integrity of the manufacturing process.

Key Responsibilities

Lead routine safety and quality walkthroughs of the production area to identify hazards and compliance gaps.
Monitor and control manufacturing process parameters to maintain product quality within defined specifications.
Lead investigations into manufacturing deviations and recommend process adjustments based on findings.
Manage risks by proactively identifying potential compliance or quality issues and implementing mitigation strategies.
Troubleshoot routine and complex manufacturing issues to restore operations and prevent recurrence.
Provide expert consultation for novel or unprecedented manufacturing challenges requiring specialized knowledge.
Monitor process alarms and respond to adverse events per established procedures to maintain safe and compliant operations.
Lead small-scale local projects to improve manufacturing processes and operational workflows.

Core Capabilities

Tackle day-to-day operational issues, diagnosing root causes and coordinating timely resolutions with teams.
Direct and coordinate team activities to maintain smooth manufacturing routines and meet daily production targets.
Uphold safety, quality and regulatory standards through rigorous adherence to procedures and incident response.
Influence management on key process decisions, acting as change agent to drive improvements across operations.
Demonstrate disciplined adherence to established routines while identifying opportunities for disciplined process enhancements.

Preferred Capabilities

Familiarity with end-to-end manufacturing processes to own and optimize routines.
Exposure to SOP drafting and revision to support consistent operations.
Experience using data insights to monitor process performance and inform improvements.
Understanding of instrumentation and measurement for process verification and control.

Requirements

Expertise in manufacturing processes
Knowledge of regulatory standards
Ability to diagnose and resolve operational deviations
Strong leadership skills
Ability to manage risks and process performance effectively
Familiarity with end-to-end manufacturing processes
Exposure to SOP drafting and revision
Experience using data insights to monitor process performance
Understanding of instrumentation and measurement for process verification and control

Benefits

401(k)
Pension
Vacation benefits
Medical, Dental & Vision
Prescription drug benefits
Flexible spending accounts
Life insurance
Death benefits
Time off
Leave of absence
Employee assistance program
Fitness benefits
Company bonus

Company overview

Eli Lilly and Company, commonly known as Lilly, is a leading American multinational pharmaceutical corporation headquartered in Indianapolis, Indiana. Founded in 1876 by Colonel Eli Lilly, the company has grown into one of the world's most valuable pharmaceutical enterprises, with operations in approximately 125 countries. Lilly specializes in developing and manufacturing innovative medicines across multiple therapeutic areas, including diabetes, oncology, neuroscience, immunology, and cardiometabolic diseases. The company is renowned for its groundbreaking work in insulin production, having been the first to mass-produce insulin and later developing the first commercially available insulin product in the U.S. Lilly's current portfolio includes blockbuster medications such as Mounjaro and Zepbound (tirzepatide) for diabetes and obesity, Trulicity (dulaglutide) for type 2 diabetes, Verzenio (abemaciclib) for breast cancer, and Taltz (ixekizumab) for autoimmune conditions. With approximately 47,000 employees worldwide, Lilly maintains a strong commitment to research and development, investing heavily in scientific innovation to address some of the world's most significant health challenges. The company operates with a mission to make life better for people around the world through the discovery and delivery of innovative medicines.