Manufacturing Specialist II, Training and Process Support

Resilience•East Norriton Township, PA

20h•Onsite

About The Position

Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. They are 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. 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 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.

Requirements

Ability to learn and master end-to-end manufacturing technologies to become a SME and ability to train operators on the floor under tight schedule.
Ability to understand and use digital manufacturing technology (MES) to execute manufacturing process.
Experience in cell and/or gene therapy manufacturing.
Good understanding of cell biology and immunology.
Emerging leadership capabilities, including a willingness and ability to coach and support the development of others.
Ability to identify and implement solutions.
Excellent oral and written communication skills with the ability to present results clearly and logically, working collaboratively as part of a team as well as independently.
Demonstrated ability to work in a dynamic, fast-paced team environment and to meet timelines.
Capable of multi-tasking and good organizational skills.
Strong knowledge of cGMP Quality Systems.
Proficient in Microsoft (Excel, Word, Outlook).
Thorough understanding of cGMPs.
Minimum 4 years relevant biopharmaceutical process manufacturing experience in a GMP field.
Previous experience managing biologics manufacturing operations.

Nice To Haves

Bachelor's degree in Biology, Biomedical Science, Chemical Engineering, Biochemical Engineering, Biotechnology or related discipline.
Minimum 2 years’ experience in cell manufacturing.
Familiarity with a wide range of cell-based techniques: cell washing/concentration (Prodigy, Lovo etc.), closed-system cell culture in various cultivation vessels (Bags, bioreactor etc.), cell formulation and cryopreservation (manual, automated device, controlled-rate freezing).
Experience in gene-modified T-cell manufacturing in a regulated environment.

Responsibilities

Leadership and accountability for people management activities for a designated team within Manufacturing.
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 manufacturing area demonstrating unit operational and end-to-end understanding.
Perform processes in accordance with cGMP, company procedures, and relevant regulations.
May require some weekend, late evening, and overtime to support manufacturing operations.