We are seeking highly motivated individuals to join the Manufacturing team at Kriya Therapeutics.
Manufacturing Associates are responsible for executing the production of clinical and/or commercial Viral Vector in one or more areas of Kriya’s RTP Viral Vector Manufacturing facility. Manufacturing Associates have a strong background in Good Manufacturing Practices and prior experience in Biologics and/or Gene Therapy Manufacturing.
• Perform GMP Viral Vector Drug Substance and/or Drug Product manufacturing operations.
• Operates manufacturing equipment and instrumentation as part of batch record execution. Typical unit operations include:
o Expansion of Cell Culture in Shake Flasks using Aseptic Technique
o Operation of Single Use Bioreactors, up to 3,000L scale
o Purification of Drug Substance using Chromatography and TFF
o Drug product vial filling
o Preparation of buffers from stock raw materials including the mixing, testing and filtration for further process needs
o Integrity testing of filters
o Operating basic analytical instruments (pH, conductivity, osmolality)
• Assist in GMP manufacturing operation start-up activities, including but not limited to:
o Authoring MFG documentation (SOPs, batch records, reports, risk assessments)
o Small equipment and material ordering & management
o Supporting Process Equipment Commissioning and Qualification
• Using Good Documentation Practices, Maintain accurate records and thoroughly document work through data entry into electronic systems, with minimal supervision
• Experience in GMP manufacturing
• Highly self-motivated and detail-oriented, with proven ability to foster strong relationships with other team members and stakeholders
• Experience with mammalian cell culture, purification, and/or drug product filling
• Experience with viral vector production
• Facility start-up experience
• Experience working in a cleanroom environment with full clean room gowning and good aseptic technique.
• Experience with single-use technology, including single use bioreactors, single use chromatography systems, and single use mixers
• Operating knowledge of AKTA systems and Unicorn methods
• Ability to perform as the Subject Matter Expert (SME) on a variety of projects and range of technologies.
• 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.
• Job level is commensurate with experience and education
• Minimum of associate degree preferably in Science, Engineering or other related field and 0-2 years of relevant related experience.
• OR Minimum of 4 years in the workforce, with a Bioworks certificate or equivalent training preferred
This is an exciting time to participate in the field of gene therapy in general, and to become a part of Kriya Therapeutics’ fast-growing dedicated team. Kriya Therapeutics offers an exciting, meaningful and collaborative fast-paced environment with a foundation of sound and rigorous science. Competitive compensation and benefits package can be expected.
To apply for this job please visit workforcenow.adp.com.