Manufacturing Team Lead

Piramal; Lexington (KY); On-site; USD 60,000 - 85,000; Full time

Job summary

A leading company in Pharma Solutions seeks a Manufacturing Team Lead in Lexington. You will be responsible for overseeing manufacturing processes, ensuring compliance with cGMP, and leading a team in a clean and safe environment. Applicants should possess at least 2 years of relevant experience in a pharmaceutical setting and demonstrate strong communication and mechanical skills.

Qualifications

• Minimum 2 years of experience in aseptic or cGMP pharmaceutical manufacturing environment.
• Ability to follow regulatory requirements (cGMP, OSHA, FDA).
• Track record of consistent attendance and reliability.

Responsibilities

• Assist operators with task checking, trouble-shooting, and product change-overs.
• Ensure cleanliness and orderliness of manufacturing area.
• Coordinate training for new hires and monitor daily operations.

Skills

Effective communication

Mechanical aptitude

Understanding of cGMP

Team collaboration

Reliability

Education

High School education or equivalent

Job description

Business: Pharma Solutions
Department: Operations
Location: Lexington

Job Overview

The Manufacturing Team Lead serves the point person and on-the-floor resource for manufacturing operators, as well as performs all activities related to the preparation, filling, capping, autoclaving, terminal sterilization, compounding, and lyophilization production.

Reporting Structure

Directly reports to Manufacturing Supervisor

Key Responsibilities

• Assists operators by accurately checking processes and tasks or setting-up, trouble-shooting and product change-overs
• Ensure housekeeping activities are completed, ensure cleanliness and orderliness of manufacturing area at all times
• Ensure correctness of team’s manufacturing documentation
• Coordinate and provide on-the-job training to new hires
• Perform end-of-shift reports, as needed
• Performs line clearances, cleaning/sanitization, cleaning, preparing and sterilization of fill equipment, sterilization of components, operation of aseptic filling equipment, filter testing, operation vial washing equipment
• Operate and maintain production related equipment
• Weigh, measure and check raw materials to assure batches manufactured contain proper ingredients and quantities
• Execute validation protocols for processes and equipment
• Maintain records and a clean environment to comply with regulatory requirements
• Read, understand, and comply with Good Manufacturing Practices and Standard Operating Procedures.
• Assists operators by accurately checking processes and tasks or setting-up, trouble-shooting and product change-overs
• Monitor and may perform daily operations and provide direction to staff as needed to maintain safe and cGMP compliant work environment.
• Monitor batch production records and documentation entries throughout the manufacturing/packaging/inspection process to ensure timely closure.
• Helps to ensure compliance with all government and company regulatory requirements to ensure applications of cGMP compliance with respect to staff, areas, documentation, and quality requirements.
• Other duties as assigned
  

Education Requirements

• High School education or equivalent

Experience

• Minimum 2 years of experience in an aseptic, or other cGMP pharmaceutical manufacturing environment

Competencies

• Ability to communicate effectively and lead a team
• Mechanical aptitude, ability to operate processing equipment
• Prior knowledge and/or ability to understand and follow job related regulatory requirements (cGMP, OSHA, FDA)
• Ability to read, interpret, and follow written instructions
• Team player committed to quality and working effectively with others
• Track record of consistent attendance and overall reliability