Production Operations Support

  •  

Suitland, MD

Industry: Government & Non-Profit

  •  

Less than 5 years

Posted 40 days ago

  by    Ravinder Telugu

Direct Client is Hiring Please go through the below Job description let me know if you are interested

Position: Production Operations Support

Location: Suitland MD

Duration: Fulltime

Description

  • Assist in the maintenance of existing and implementation of new/additional low/medium complexity Client Programs through:
  • Operational assessment of client technology, resource and logistics 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

Knowledge and Experience:

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