Manufacturing Team Lead

Piramal•Lexington, KY

About The Position

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. Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers 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 such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.

Requirements

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

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