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Manufacturing Team Lead - 2nd Shift

Job Details

Company Headquarters - Lexington, KY
Full Time
2nd Shift


Responsible for independently performing and leading routine tasks in the manufacturing of nasal spray drug products with supervision.


Essential Duties:


  • Work in a safe manner in accordance with site procedures.
  • Adhere to cGMPs and SOPs.
  • Lead team in following Production Batch Records (PBRs) to operate, monitor and control equipment and process parameters during manufacture.
  • Lead team in following SOPs to clean, sanitize and prepare process equipment and rooms for manufacturing. 
  • Complete PBRs, Log Books, Forms and other documentation. Assist in compilation and review of log packets.
  • Review and revise SOPs and Forms to ensure they accurately reflect the current procedures.
  • Maintain assigned manufacturing area in accordance with 5S.
  • Lead training of other manufacturing team members.
  • Assist with the execution and review of validation protocols for manufacturing/support equipment.
  • Recommend and implement manufacturing or facility related improvement projects, continuous improvements, or cost savings opportunities.
  • Assist in coordinating manufacturing, calibration and maintenance activities with other departments.
  • Mentor Manufacturing Technicians.
  • Understand daily priorities and organize daily activities and job assignments within designated process operation.
  • Ensure team compliance with Summit Biosciences, Inc. Employee Handbook lunch and rest policies.
  • Report daily progress to Manufacturing Management.
  • Set the pace of the operation to ensure work is performed in a consistent manner while maintaining high safety and quality standards.
  • Other duties as assigned.


Knowledge, Skills and Abilities:


  • Technician I for two years and cross-trained in five training module areas plus 50% in all other areas.
  • Good understanding of GMP’s
  • Demonstrated mechanical problem-solving skills.
  • Documentation error rate of less than 3%.
  • Less than two Quality events in a year.
  • Must have legible handwriting.
  • Develops strong relationships and leads team to achieve results.
  • Leads team during problem solving and understands two – three problem solving methods.
  • Well-developed written and verbal communication skills.
  • Demonstrates self-control to others when dealing with stressful situations.
  • Outstanding capability to be flexible, adaptable and self-motivated in response to changing conditions and schedules.

















  • High School Diploma or GED
  • Preferred at least 3 - 5 years of applicable experience in GMP pharmaceutical manufacturing environment or equivalent experience.
  • Qualified to work with controlled substances.