Legend Biotech US
Operations Associate
Raritan, New Jersey, United States
Sponsorship not specifiedDetected 7 days ago
GMPCommunicationCollaborationGxP
About the role
- This position is responsible for performing manufacturing procedures and the execution of scheduled tasks within a CGMP environment.
- This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.
Responsibilities
- Independently execute manufacturing or manufacturing-support processes according to standard operating procedures and current curriculum.
- Perform process unit operations according to standard operating procedures and batch records, and record production data and information in a clear, concise, format according to Good Documentation Practices (GDP).
- Perform tasks on time in a manner consistent with quality systems and cGMP requirements.
- Drive continuous improvement of manufacturing operations leveraging own observation as well as input of team members.
- Support schedule adjustments to meet production.
- Accurately complete documentation in SOP's, logbooks and other GMP documents.
- Proactively maintain a clean and safe work environment. Take necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors
- Perform other duties as assigned.
- Learn new skills, procedures and processes as assigned by management and continue to develop professionally.
Requirements
- HS Diploma required with 3.
- 5 Years Biotech/Pharmaceutical experience or equivalent industry experience // OR // Associates Degree required in Life Sciences or Manufacturing with 2.
- 3 years of related experience // OR //Bachelors Degree required in Life Sciences with 0.
- 2 years Biotech/Pharmaceutical experience or equivalent industry experience
- Knowledge of Process Excellence Tools
- Possesses solid knowledge of routine and non-routine testing and sampling methods, techniques and related equipment.
- Work in a team based, cross-functional environment to complete production tasks required by shift schedule.
Company info
- Be part of the manufacturing operations team responsible for production of autologous CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice (cGMP) cleanroom environment.
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This listing is sourced directly from Legend Biotech US's careers page and normalized into a canonical job model.