About The Position

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. The role maintains safe, compliant operations by monitoring process alarms and responding to adverse events according to established procedures, while providing expert consultation for novel or unprecedented manufacturing challenges. The Supervisor diagnoses and troubleshoots routine and complex issues to restore and sustain production, with a focus on quality, compliance, and proactive problem solving. The role also guides teams in applying production management best practices to minimize recurrence and protect the integrity of the manufacturing process. The position directs and coordinates team activities, supports daily production targets, and leads small-scale local projects to improve manufacturing processes and workflows. It works to uphold safety, quality, and regulatory standards and to influence process decisions and improvements across operations.

Nice To Haves

  • Familiarity with end-to-end manufacturing processes to own and optimize routines.
  • Exposure to drafting and revising standard operating procedures (SOPs).
  • Experience using data insights to monitor process performance and inform improvements.
  • Understanding of instrumentation and measurement for process verification and control.

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.
  • Proactively identify potential compliance or quality issues and implement 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 according to established procedures to maintain safe and compliant operations.
  • Lead small-scale local projects to improve manufacturing processes and operational workflows.
  • Diagnose day-to-day operational issues, identify root causes, and coordinate 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 adherence to procedures and incident response.
  • Influence management on key process decisions and drive operational improvements.
  • Follow established routines while identifying opportunities for process enhancements.

Benefits

  • Company bonus, depending in part on company and individual performance.
  • Eligibility to participate in a company-sponsored 401(k).
  • Pension.
  • Vacation benefits.
  • Eligibility for medical, dental, vision, and prescription drug benefits.
  • Flexible benefits, such as 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, including an employee assistance program, fitness benefits, and employee clubs and activities.
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