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Manufacturing Development

Organizational Relationships:

  • Reports to Director of Manufacturing and Process Development  
  • Will work under the guidance of the Director of Manufacturing and Process Development to coordinate and perform assigned responsibilities to support the Company’s product manufacturing process improvement initiatives. 
  • Will participate in the evaluation process of new technologies and its applicability to the product manufacturing process.  Essential to this role is the ability to contribute technical expertise to the manufacturing process while optimizing process performance and quality.  The demands of this role command strong direct experience and a thorough understanding of GMP techniques and modern manufacturing methodologies.

Position Overview:

  • Work as part of a multidisciplinary project team to develop innovative technology and process improvements.
    • Coordinate the activities of the process development team in the optimization, scale up, and scale out of the manufacturing process;
    • Evaluation of new techniques and technologies; and
    • Active participation in the assessment of the Company’s technology platform to new disease indications.
  • Responsible for the experiment, design and execution of the planned work, data analysis and interpretation, and  presentations.
    • Provide regular updates, documentation and communication of project results;
    • Demonstrates the ability to correctly analyze and interpret outcomes of experiments and report data;.
    • Communicates own work orally and in writing and provides input for scientific reports; and
    • Reports and treats data with a high level of integrity and ethics.
  • Demonstrate ability to define, investigate and solve complex problems using diverse established and experimental procedures.
  • Implement and maintain procedures to ensure compliance with company quality system, safety systems and technical excellence.
    • Maintaining comprehensive records of all work and write and review formal reports;
    • Provides the data in a quality presentation form (graphs, figures, tables, etc.) to support regulatory submissions and peer-reviewed publications; and
    • Generates and maintains necessary batch records, SOPs, EOPs, and process control forms in accordance with company policies.
  • Contribute to project teams through lab-based activities.
  • Coordinate and perform the technical transfer of knowledge, procedures, process improvements and techniques to manufacturing personnel and other appropriate departments.
  • Other research and development tasks as assigned.

Minimum Education and/or Experience Required:

  • Minimum 3 years of experience in the implementation of process development and/or manufacturing of cellular based products.
  • Bachelor’s Degree with a medical technology or blood banking discipline is desirable.  A college degree in a scientific discipline in conjunction with relevant working experience is also acceptable.

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