Associate Manufacturing Engineer

Role Overview

The Associate Manufacturing Engineer, Tech Support will be part of the Technical Support team and be responsible to support the development and routine operation of a new CAR-T manufacturing process. They will be a subject matter expert for the manufacturing process and equipment primarily responsible for providing front line support to address and resolve manufacturing issues.

Key Responsibilities

• This individual will partner closely with Quality, Compliance, and technical experts to drive accelerated, robust, and consistent resolution and escalation of process issues as applicable while ensuring batch quality and adherence to procedures and instructions.
• Support compliant manufacturing investigations and CAPAs, as subject matter experts.
• Be a point of contact with equipment suppliers for timely and continuous support.
• Understand key process indicators of the manufacturing process and process execution and support opportunities for improvement and waste reduction.
• Perform regular manufacturing observations to collect process health data for the identification of process improvement and waste reduction opportunities.
• Act as a primary point of contact across all manufacturing and support organizations. Ability to interact with all levels within the organization.Act as a primary point of contact across all manufacturing and support organizations. Ability to interact with all levels within the organization.

Requirements

• A minimum of a Bachelor's degree in engineering or related field or equivalent experience required. Advanced degree preferred.
• 2-3 years of operations experience within a cGMP environment in the biotech/biopharma industry and Cell/Gene Therapy cGMP manufacturing experience preferred.
• Provide support and technical expertise to the Manufacturing team in support of ongoing manufacturing operations.
• Ability to accommodate changes in the schedule including working on shift as necessary to support operational needs.
• Support initiatives for process, operational, and quality improvements for manufacturing.
• Maintain processes at a state of audit readiness and support internal and external inspections as required.
• Support writing of SOPs for Manufacturing and Quality Risk Assessments for existing and new/changed processes.
• Ability to work with oversight and successfully execute and manage tasks for timely completion, Must respond to shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• Support the Manufacturing team to troubleshoot and resolve complex scientific/technical problems.
• Provide technical expertise to support the implementation of process improvements that would provide reduction in COGs, increase throughput, capacity and quality compliance.
• Build strong partnerships with Manufacturing, Engineering and Quality to ensure seamless execution of daily production schedules.

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The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay):

$78,251-$102,705 USD

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.