What are the responsibilities and job description for the Manufacturing Team Leader position at Piramal Enterprises?
Business: Pharma Solutions
Department: Pharmaceutical Production
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
Manufacturing Supervisor
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
In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.
Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunity
Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.
We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
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.
