Associate Technical Lead

Legend Biotech • Raritan, NJ

311d

About The Position

Legend Biotech is seeking Associate Technical Lead as part of the Technical Operations team based in Raritan, NJ. The Associate Technical Lead will be part of Technical Operations and will be responsible for supporting the Manufacturing Excellence team as a technical individual contributor by providing specialist knowledge and expertise of cell and gene therapy processes and/or process technologies. This individual will also oversee the processes and standards to maintain and improve existing and to implement new innovative manufacturing technologies.

Requirements

• A minimum of a Bachelor's degree in engineering or related field or equivalent experience required. Advanced degree preferred.
• 8 years of operations experience within a cGMP environment in the biotech/biopharma industry. Cell/Gene Therapy cGMP manufacturing experience preferred.
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously.
• Integrate cross-functional issues and balance competing priorities effectively.
• Support Manufacturing team to troubleshoot and resolve complex scientific/technical problems.
• Provide technical expertise to drive the implementation of process improvements.
• Provide technical expertise in automation projects from user requirements to testing and implementation in a GMP manufacturing environment.
• Perform technical feasibility studies related to process improvement and implementation of new manufacturing technologies.
• Build strong partnerships with Manufacturing, Engineering and Quality.

Nice To Haves

• Strong analytical, problem solving and critical thinking skills.
• Clear and succinct verbal and written communication skills.
• Ability to accommodate shift work including evenings and weekends as required by the manufacturing process.
• Ability to accommodate unplanned overtime on little to no prior notice.

Responsibilities

• Provide direct support to the Director of Manufacturing Excellence by providing technical expertise to Technical Operations and ensure safe and compliant manufacturing operations according to cGMP requirements.
• Support the hiring and development of Manufacturing Excellence associates.
• Own the process knowledge of the cell and gene therapy manufacturing process technology and maintain oversight on process capability to ensure processes are robust and continuously improving.
• Work with the Data Management and Integration Lead and Process Validation lead on the establishment and management of a process monitoring program.
• Establish metrics for process and team performance.
• Ensure seamless flow of knowledge and information across functions, and with other sites when applicable.
• Provide technical/scientific process support.
• Support manufacturing investigations, manage change controls and maintain permanent inspection readiness.
• Actively support regulatory inspections.
• Support the implementation of manufacturing and process automation strategies through cell therapy manufacturing process design qualification.
• Write and/or review user requirements, functional requirement specifications, qualification protocols, and process development reports.
• Provide technical assessments, rationales, and approval for engineering and process changes to meet regulatory requirements.
• Work closely with cross-functional teams to design and implement cell therapy processes.
• Manage equipment qualification strategy and support process validation activities for cell therapy platforms.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree