Manufacturing Specialist II, Training and Process Support

A career at Resilience is more than just a job – it’s an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. 

For more information, please visit www.resilience.com

General Company Description

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need. 

For more information, visit  www.resilience.com.

Position Summary & Role

The Manufacturing Specialist II, Training and Process Support, position is responsible for developing and managing the training and compliance associated with clinical manufacturing of cell and gene therapy products according to current Good Manufacturing Practices (cGMPs) and procedures. The position will report to the Manufacturing Manager.

The position requires knowledge and scientific background in manufacturing operations and demonstrated skills in scientific innovation, independent thinking, and cross-functional collaboration. Previous experience managing biologics manufacturing operations is required, and experience in gene-modified T-cell manufacturing in a regulated environment is strongly preferred.

Job Responsibilities

• Leadership and accountability for people management activities for a designated team within Manufacturing.
• This position has the ability to be a people manager based on need.
• Works cross-functionally with all departments onsite to develop and maintain training materials and curricula on process operations, theory, and compliance.
• Works with associated quality teams to follow and improve currently established standard operating procedures and identify gaps where new procedures may be required.
• Must assist with overseeing day-to-day operations and ensure compliance.
• Ensure Manufacturing is always in a state of Audit Readiness.
• Lead/Assist all internal, client, and regulatory audits.
• Oversees the training of new Manufacturing personnel.
• Assists with training, as needed, with staff on the floor.
• Participates on cross functional teams to drive investigation close outs, determine root cause and implement appropriate Corrective and Preventative Action.
• Organizes and participates on cross-functional continuous improvement teams with Process Development, Quality Assurance, Quality Control, Facilities, and Manufacturing Technical Services.
• Manage the department Aseptic Operator Qualification program.
• Understands, performs, and trains on aseptic technique at an expert level and can identify unacceptable practices and make spot corrections to performance.
• Understands and can train on all operations, functions and capability of equipment.
• Assists supervisors with oversight the manufacturing process, supervises processing on the floor, and delegates daily work assignments.
• Performs well under direct supervision and works independently on complex tasks and processes.
• Identifies, understands and able to explain the ‘why’ of acceptable and unacceptable practices. Must be able to make on the spot corrections to performance and provide a future training on the issue.
• Collaborate with Manufacturing Sciences, Quality, Quality Control and Engineering & Facilities Management teams to ensure continued support for Manufacturing.
• Author, execute, and review documents including but not limited to: SOPs, batch records, and qualification / validation documents.
• Lead the completion of quality documentations, such as Change Controls, deviation investigations and CAPA activities.
• Ensure team adheres to health and safety standards and regulations.
• Lead, assist and/or perform qualification and validation activities including equipment qualification, aseptic qualifications, and process qualification / validation.
• Understands, trains and coaches others on all operations, functions, capability of equipment and ancillary support to equipment and can perform complex troubleshooting.
• Identifies, suggests with options, recommends path forward and leads complex decision-making sessions.
• Possesses basic and fundamental engineering and mechanical knowledge and can apply in the manu