Production Support Associate I

Minaris Advanced Therapies•Allendale, NJ

9d•$28 - $30•Onsite

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.

Requirements

Bachelor’s degree in relevant life science or engineering discipline.
Minimum of 2 years combined industry/academic experience in cell processing, cell culture, cell analytics, and related GMP technologies, preferably for manufacture of cell therapy products.
Demonstrated excellence in technical writing in the preparation of, protocols and reports, presentations and/or other communications.
Understanding of the technical principles, theories and concepts of low complexity technology transfer and the manufacturing of cell therapy or similar products.
Ability to provide technical solutions to a variety of technical problems of low complexity scope and the ability to suggest improvements and adaptations to methodologies, processes, products.
GMP training
Gowning training/qualification
Aseptic process qualification (personal media fill)
Aseptic Processing Standards
The employee must be able to comply with HCATS personal hygiene standards as they apply to aseptic processing.
The employee must successfully complete sterile gowning training/qualification and aseptic process qualification (personal media fill) as well as annual/semiannual re-qualification as a core competency requirement of their employment in this role.

Nice To Haves

Prior experience with development or use of closed systems or automation for cell therapy manufacturing is desirable.

Responsibilities

Assist in the maintenance of existing and implementation of new/additional low/medium complexity Client Programs.
Assess client technology, resource and logistics assessment efforts in preparation for tech transfer to the any of the PCT facilities.
Supporting Operations Technical Trainers with the development of the Training Plans.
Identification of the requisite skillset and competencies for the program-specific tech transfer team and working with relevant functional leads to assemble to team.
Knowledge transfer/training as defined in the Training Plan.
Participation in the monitoring, evaluation and documentation of the knowledge transfer/training outcome.
Coordination of the technology implementation team to deliver key implementation milestones such as: development and implementation of program-specific documents (i.e., Master Batch Records, SOPs, Test Methods, ancillary protocols) within the document control system; facilitating raw material sourcing; facilitating raw material sourcing; facilitating equipment and instrument commissioning; establishing the development/facility resources;; effective transfer of the manufacturing process and procedures; final documentation.
Support Training, Engineering and Clinical Readiness runs to meet project timelines/deliverables.
Write internal technical documents, such as protocols (i.e.; Engineering, Clinical Readiness, APS, etc…), reports, SOPs, and work instructions.
Execute assignments in alignment with pre-planned scope of work, timeline, and budget.
Collaborate with adjacent functions.
Serve as Subject Matter Expert for cell therapy processes where sufficient knowledge and experience has been demonstrated.
Perform work within the context of sound scientific and engineering principles and consistent with relevant industry practices such as, Quality by Design (QbD) and Good Manufacturing Practices (GMP).
Support the efficient operation of development laboratories.