MSAT - Engineer

Minaris Advanced Therapies•Allendale, NJ

About The Position

Be part of something bigger at Minaris Advanced Therapies—where every role contributes to creating hope for patients around the world. As a global leader in cell and gene therapy development, manufacturing, and testing, we turn breakthrough science into real-world treatments that change lives. Our team of over 1,000 experts across North America, Europe, and Asia has helped bring transformative therapies to market. At Minaris, you’ll join a purpose-driven community focused on innovation, collaboration, and patient impact. Whether you’re in the lab, in the cleanroom, or behind the scenes, your work will directly support life-saving therapies and make a lasting difference. If you're passionate about advancing cutting-edge science and believe in the potential of cell and gene therapies, we invite you to help shape the future of medicine—one patient at a time. Position Summary Perform process and analytical experimental studies as part of a team that effectively delivers cell therapy services to clients in accordance with the defined scope of work, timelines, and budgets. This includes leading projects in process development, technology transfer and continuous improvement of our client’s novel manufacturing processes. Our goal is to support our clients in developing commercially viable cell therapy products so that they become accessible to all.

Requirements

Collaboration, Accountability, Adaptability, Can-do, Technical Capacity, Problem Solving, Customer-centric, and Good communication
Minimum of a bachelor’s degree in relevant life science or engineering discipline
Minimum of 3 years’ experience in aseptic cell processing, cell culture and cell analytics under the guidance of scientific protocols
Demonstrated ability to deliver projects to specific timelines and budgets
Experience in working effectively and delegating tasks in a team-based environment
Demonstrated ability in technical writing and the preparation of, protocols and reports, presentations and/or other communications
Basic understanding of the technical principles, theories, and concepts of cell therapy or similar products
Ensure compliance with all FDA and Worldwide Quality & Compliance regulations in all aspects of your work.
Adhere to established procedures and protocols, prioritize continuous training and skill development, and uphold the highest standards of data integrity to ensure accuracy, compliance, and operational excellence.

Responsibilities

Regular and reliable attendance on a full-time basis.
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture.
Accountable for the design and execution of projects in the laboratory, for example:
Perform laboratory experiments for client projects
Perform analytical testing for client projects
Preparation and scheduling of laboratory equipment for experiments
Lead the generation of manufacturing and development documentation, for example:
Generate experiment protocols and reports for development projects
Generate draft batch records and other manufacturing documentation
Generate manufacturing risk assessments, such as FMEA
Perform data analysis to reach actionable conclusions, for example:
Compile and analyze experimental data
Present experimental data internally and externally to clients
Provide technical leadership of client products during manufacturing and development, for example:
Direct technical communication with clients during manufacturing and development
Support manufacturing in identifying and resolving manufacturing process constraints
Participate in strategic planning and implementation for MSAT functions
Maintain process-specific resource models and communicate changes
Maintain process-specific dashboards and perform data trending analysis
Maintain process design history files and perform analysis
Assess new opportunities by evaluating process/QC for technical transfer readiness; support the sr. engineer/scientist as needed
Support the team with the master transfer plan during technology transfer post-establishment of the strategy
Advocate for hiring for PPU and identify skills sets needed (potentially go to S&OP)
Facilitate inter/intra-departmental communication
Communicate with clients about potential upsell and interface with account management and Mdev for availability
Serve as the main point of contact with the project manager on technical matters and communicate interactions to the team
Serve as the main point of contact for the client project-specific, technical matters and create proper communication channels
Align with the Production Support manager on roles within PPU; align on RACI (raise issues to the director)
Demonstrate leadership and mentorship
Demonstrate the ability to align with functions
Could have direct reports
Perform team building for effective internal information transfer
Build Quality into all aspects of your work by maintaining compliance to all quality requirements.
Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
Attend all required Quality & Compliance training at the specified interval