Director Cell Production Process and Development

Aurion Biotech is the cell therapy division of CorneaGen, a mission-driven company committed to transforming how corneal surgeons treat and care for the cornea. Based in Seattle and Boston, Aurion Biotech is developing novel cell therapies for ocular diseases.  Aurion’s mission is to cure leading forms of blindness and transform the lives of millions of patients, by developing and advancing a portfolio of novel cell therapies, gene therapies and biologics.

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Essential Duties and Responsibilities:  

  • Develop an innovative technology platform for intra-ocular delivery of cell therapy products. 

  • Develop technologies that streamline cell therapy manufacturing for clinical use. 

  • Establish process parameters and contribute to CMC sections of regulatory filings. 

  • Lead technology transfer to manufacturing and provide training for GMP production. 

  • Partner with QA to develop and implement phase-appropriate quality systems. 

  • Coordinate and integrate the activities of various internal and external organizations (CMOs, CROs) to ensure alignment in scope, schedule and budget. 

  • Identify raw materials and support the establishment of raw materials specifications. 

  • Ensure timely completion of activities needed for Investigational New Drug (IND) applications with the US Food and Drug Administration (FDA). Support filing activities as needed. 

  • Other duties as assigned. 

 

Qualifications: 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

 

Education and Experience: 

  • PhD in Life Sciences, Chemical engineering, Bio-engineering, or related discipline with minimum 6 years of relevant industrial work experience or Master’s degree with 10 years of industry experience 

  • Management experience preferred. 

  • 5+ years of demonstrated process development experience in a bio-pharmaceutical setting working with interdisciplinary and cross-cultural teams. 

 

Required Skills/Knowledge/Abilities: 

  • Experience leading multidisciplinary teams (biologists, chemists, software engineers, mechanical engineers), including CMOs and CROs is preferred 

  • Demonstrable productivity in the form of patents, publications and presentations. 

  • Experience with GMP-compatible biomaterials is preferred. 

  • Experience validating technologies in O.R. settings (pre-clinical or clinical) is preferred. 

  • Able to work well with others in a collaborative and respectful manner.  

  • Able to multi-task, deal with complexity on a frequent basis.  

  • Essential to perform all functions of the job accurately and in a timely manner. 

  • Able to work under pressure and time constraints.   

  • Able to arrive for work on time and maintain a good attendance record.  

  • Ability to maintain a professional demeanor and confidentiality.

  • Demonstrates passion for the Mission and Values of CorneaGen, including personal support of organ and tissue donation.