Manufacturing Team Lead

Piramal Critical Care, Inc.; Lexington (KY); On-site; USD 70,000 - 95,000; Full time

Job summary

Piramal Pharma Solutions in Lexington, KY, is seeking a Manufacturing Team Lead to act as the on-the-floor resource for manufacturing operators, overseeing aseptic processes and advanced production steps. You will guide daily operations, ensure documentation accuracy, and maintain cGMP compliance.

The role reports to the Production Supervisor, with responsibilities spanning process checks, setup, troubleshooting, training, and ensuring a clean, compliant manufacturing environment.

Qualifications

• High School education or equivalent.
• Minimum 2 years of experience in an aseptic, or other cGMP pharmaceutical manufacturing environment.
• Ability to communicate effectively and lead a team.
• Mechanical aptitude and ability to operate processing equipment.
• Knowledge of regulatory requirements (cGMP, OSHA, FDA).
• Ability to read, interpret, and follow written instructions.
• Team player with reliability and consistent attendance.

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

Skills

Team leadership

Communication

Mechanical aptitude

Regulatory knowledge (cGMP/OSHA/FDA)

Reading/writing instructions

Education

High School degree or equivalent

Job description

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Division

Piramal Pharma Solutions
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title
Manufacturing Team Lead
Job Description
Business: Pharma Solutions
Department: Operations (OPS)
Location: Lexington
Job Overview

Reporting to the Production Supervisor, 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.

Shif t

Days

Reporting Structure

This position reports to the Production 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

Qualifications

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