Lead Engineer, Drug Product

Location
Morrisville, NC
Posted
Jan 21, 2022
Ref
1006
Hotbed
Bio NC
Required Education
Associate Degree
Position Type
Full time
Company Summary:

Kriya is a next generation gene therapy company focused on expanding the field to new frontiers. We have built a fully integrated, technology enabled platform for rational vector design, analytical characterization, and scalable manufacturing to design and develop gene therapies for diseases with well-understood underlying biology. We believe that rationally engineered gene therapies can transform the treatment of a broad universe of diseases – and we are prepared to lead this revolution in medicine.

Our team is made up of leading scientific experts who are passionate about improving patients’ lives and easing the burden of these life-changing disorders for patients. We are looking for teammates with the ambition, creativity, and energy to help us build a unique organization.

If you are looking to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, Kriya is the company for you.


Position Summary:

The Lead Engineer/Scientist is an integral part of the Manufacturing Sciences Organization and is responsible for supporting the production of clinical and/or commercial Viral Vector in one or more areas of Kriya’s RTP Viral Vector Manufacturing facility with primary support for Drug Product and Filling.  The focus of this position is to provide vector drug product process support and expertise for leading and managing process transfer to support GMP manufacturing operations.

The Manufacturing Science Organization, which will consist of process engineers and scientists: 

  • Facilitates Tech Transfer of Viral Vector Programs from Process Development into Manufacturing 
  • Provides Technical Support to the Manufacturing Organization eg. Investigation/deviation support
  • Design and execute phase appropriate studies to support product development and regulatory filings 

It is expected that members of the Manufacturing Science Organization have a strong background in Process Engineering, GMP Biotechnology, and/or Gene Therapy experience.


Primary Responsibilities:

  • Serve as the technical expert for drug product manufacturing
  • Define, measure, analyze, and propose improvements to the current process and systems.
  • Participates in or leads (as necessary) cross functional teams for tech transfer and manufacturing support. May participate on sub-teams and work as a point of contact for programs.
  • Provide technical support of GMP manufacturing runs and hands-on support as needed for rapid troubleshooting.
  • Author and execute engineering studies, technical reports, material assessments, and process validation protocols.


Qualifications:

  • Experience in GMP manufacturing or manufacturing support, strong preference for aseptic manufacturing experience
  • Experience with drug product filling operations and supporting studies
  • Highly self-motivated and detail-oriented, with proven ability to foster strong relationships with other team members and stakeholders
  • Facility start-up experience is preferred
  • Experience working in a cleanroom environment and good aseptic technique.
  • Perform as the Subject Matter Expert (SME) on a variety of projects and range of technologies.
  • Master's degree, preferably in Science, Engineering or other related field and 2-4 years of relevant related experience OR
  • Bachelor’s degree, preferably in Science, Engineering or other related field and 4-6 years of relevant related experience OR
  • Associate’s degree, preferably in Science, Engineering or other related field and 6-8 years of relevant related experience.


Working Conditions:

  • Must have flexible work hours, and be willing to work outside of normal, scheduled hours; as necessary. Must be able to work alternative shift hours and weekends as required.

 

 

Kriya is an equal opportunity employer. 

We celebrate diversity and are committed to creating an inclusive environment for all employees.