Process Engineer IV- Cell Therapy, MSAT

Resilience • East Norriton Township, PA

6d • $115,000 - $163,750 • Onsite

About The Position

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 The Process Engineer will work in the Manufacturing Science and Technology (MSAT) group to provide technical support to clinical operations at the Philadelphia, PA site. The responsibility of this role is to support cell therapy production. Job Responsibilities · Leading the introduction of new manufacturing processes to facility clinical and commercial manufacturing of drug substance for biologics and/or nucleic acids. · Performing technology transfer from the development laboratory into all phases of GMP manufacturing. · Supporting process investigations, equipment and process troubleshooting. · Identifying and driving implementation of improvements to maximize throughput and capacity utilization. · Defining relevant operational/technical standards and practices for the site. · Providing support and content for regulatory submissions The primary objective is to ensure manufacturing processes are capable, compliant, in control, and continuously improved. · Function as a technical resource for the resolution of deviations, investigations, and process issues. Complete technical investigations and provides on the floor technical expertise. · Generate technical documents (memos, protocols, reports, plans, etc.,) related to technology transfer, process monitoring, process improvements, etc. · Actively participate in client meetings and serve as a technical SME. · Complete process monitoring tasks that require a variety of statistical and data analysis methods and techniques. · Routinely troubleshoot operational issues for process related operations. · Be a technical resource in the evaluation and implementation of process improvements, policy changes, compliance improvements and optimization programs. Process Design for Scale-up to Manufacturing · Provide technical leadership for execution of engineering runs during technology transfer from development to manufacturing. · Monitor, track, evaluate, and report data from unit operations to support project/client communication and deliverables. · Perform statistical analysis. · Respond to and trouble-shoot process issues related to · Perform material assessments as required. · Develop scientific and technical understanding of unit operations and production processes. Technology Transfer to GMP Production · Participate in technology transfer activities and provide oversight of GMP runs to support technology transfer to production. · Perform key project deliverables for technology transfer activities for new client projects. · Define and justify critical and key process parameters. · Participate in the development of specifications, standard operating procedures, work instructions and forms to support implementation of new processes. · Collaborate with manufacturing as well as all support functions such as engineering, quality, and supply chain to provide robust and coordinated support. · Perform and/or support risk assessment activities including hazard and operability studies. · Train production staff to ensure they can perform duties involving new equipment and new processes. · Generate protocols and reports for engineering, and clinical GMP runs. · Prepare change controls and perform change control assessments according to internal procedures as required. · Comply with safety requirements and work to resolve any environmental, health and safety issues. · Optimize processes to effectively and efficiently produce product that meets clients’ quality specifications.

Requirements

• Demonstrated technical, operational, and hands-on equipment knowledge in cell and gene therapy or other related biopharmaceutical manufacturing modalities, with experience in process data analysis.
• Experience participating in technology transfer activities, with exposure to cross-functional collaboration during transfer processes.
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
• Understanding of quality, compliance, regulatory, and good manufacturing practices.
• Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across functions and multiple stakeholders.
• Ability to influence others without direct authority and communicate with all levels of the organization.
• Excellent communication (oral and written) and attention to detail; ability to present and defend technical and scientific approaches and decisions in both written and verbal form to internal and external partners.
• On site work required for position
• Support production/manufacturing shift activities, which may require after hours work on occasion including weekends.
• Ability to gown.

Nice To Haves

• M.S./B.S. in Life Sciences, Chemical or Biological Engineering, Biology or related discipline with 3-5 years of relevant industry experience in process development, technology transfer, or GMP Manufacturing.
• Experience developing acceptance criteria for technology transfer.
• Hands‐on experience cell therapy biotechnology unit operations.
• Experience with single use technology and systems.
• Experience working for or with contract manufacturing organizations.
• Experience owning, managing, and executing change controls and using management systems (ex. Veeva).

Responsibilities

• Leading the introduction of new manufacturing processes to facility clinical and commercial manufacturing of drug substance for biologics and/or nucleic acids.
• Performing technology transfer from the development laboratory into all phases of GMP manufacturing.
• Supporting process investigations, equipment and process troubleshooting.
• Identifying and driving implementation of improvements to maximize throughput and capacity utilization.
• Defining relevant operational/technical standards and practices for the site.
• Providing support and content for regulatory submissions
• Function as a technical resource for the resolution of deviations, investigations, and process issues.
• Complete technical investigations and provides on the floor technical expertise.
• Generate technical documents (memos, protocols, reports, plans, etc.,) related to technology transfer, process monitoring, process improvements, etc.
• Actively participate in client meetings and serve as a technical SME.
• Complete process monitoring tasks that require a variety of statistical and data analysis methods and techniques.
• Routinely troubleshoot operational issues for process related operations.
• Be a technical resource in the evaluation and implementation of process improvements, policy changes, compliance improvements and optimization programs.
• Provide technical leadership for execution of engineering runs during technology transfer from development to manufacturing.
• Monitor, track, evaluate, and report data from unit operations to support project/client communication and deliverables.
• Perform statistical analysis.
• Respond to and trouble-shoot process issues related to
• Perform material assessments as required.
• Develop scientific and technical understanding of unit operations and production processes.
• Participate in technology transfer activities and provide oversight of GMP runs to support technology transfer to production.
• Perform key project deliverables for technology transfer activities for new client projects.
• Define and justify critical and key process parameters.
• Participate in the development of specifications, standard operating procedures, work instructions and forms to support implementation of new processes.
• Collaborate with manufacturing as well as all support functions such as engineering, quality, and supply chain to provide robust and coordinated support.
• Perform and/or support risk assessment activities including hazard and operability studies.
• Train production staff to ensure they can perform duties involving new equipment and new processes.
• Generate protocols and reports for engineering, and clinical GMP runs.
• Prepare change controls and perform change control assessments according to internal procedures as required.
• Comply with safety requirements and work to resolve any environmental, health and safety issues.
• Optimize processes to effectively and efficiently produce product that meets clients’ quality specifications.

Benefits

• Resilience offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, paid vacation, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level