Manufacturing Team Lead

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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