Manufacturing Team Lead

Piramal Pharma Limited; Lexington (KY); On-site; USD 70,000 - 90,000; Full time

Job summary

Piramal Pharma Limited in Lexington is seeking a Manufacturing Team Lead to serve as the point person on the floor for manufacturing operators and to oversee preparation, filling, capping, autoclaving, sterilization, and lyophilization processes.

You will supervise night shifts, ensure cGMP compliance, maintain documentation, train new hires, and drive continuous improvement while safeguarding safety and quality.

Qualifications

• High School education or equivalent.
• 2+ years in aseptic or cGMP pharmaceutical manufacturing.
• Ability to communicate effectively and lead a team.
• Mechanical aptitude and ability to operate processing equipment.
• Familiarity with cGMP, OSHA, FDA regulations.
• Reading and following written instructions.

Responsibilities

• Assist operators by checking processes, setting up, troubleshooting and product change-overs.
• Maintain housekeeping, cleanliness and order in the manufacturing area.
• Ensure accuracy of the team’s manufacturing documentation.
• Coordinate and provide on-the-job training to new hires.
• Perform end-of-shift reports as needed and monitor batch records.
• Operate and maintain production equipment, verify materials and weights.
• Execute validations for processes and equipment; ensure regulatory compliance.

Skills

Team leadership

Aseptic processing

Troubleshooting

Documentation

cGMP

Education

High School diploma or equivalent

Tools

Autoclave operation

Sterilization equipment

Job description

Job Title

Manufacturing Team Lead

Job Description

Business: Pharma Solutions Department: Operations (OPS) 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

This position reports to the Production Supervisor Shift Nights.

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

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.