Associate II, Manufacturing (Contract)

About Kriya 

Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world.

We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology.

We are proud to have been named Triangle Business Journal’s Life Sciences 2024 “Best Private Company to Work For” and recognized by Forbes as one of “America’s Best Startup Employers of 2024”.

Who You Are

The Manufacturing Associate II will be responsible for executing the production of AAV Vector in one or more areas of Kriya’s GMP Manufacturing Facility.  The primary focus of the GMP Manufacturing Facility is to support the advancement of programs through Kriya’s product development lifecycle through large-scale production of AAV vector to supply pre-clinical and clinical studies.  

How You Contribute

• Perform GMP Viral Vector Drug Substance and/or Drug Product manufacturing operations as directed. 
• Operates manufacturing equipment and instrumentation per Standard Operating Procedures and documents activities within Production Records. Typical unit operations include:
  1. Preparation of solutions from stock raw materials including the mixing, testing, and filtration
  2. Expansion of Cell Culture in Shake Flasks using Aseptic Technique
  3. Operation of Single Use Bioreactors 
  4. Purification of drug substance using Chromatography and TFF
  5. Drug product vial filling
  6. Visual inspection of final drug product 
• Performs routine manufacturing operations, including inventory, organization, document reviews, and routine manufacturing tasks
• Using Good Documentation Practices, maintain accurate records and thoroughly document work through data entry into electronic systems, with minimal supervision
• Perform additional manufacturing tasks as assigned

What You Bring to the Team

Education & Experience

• Bachelor’s degree preferably in Science, Engineering, or related field and 1 year of relevant related industry experience 

        OR

• Associate degree preferably in Science, Engineering, or related field and 2+ years of relevant related industry experience.  

        OR

• Bioworks certificate or equivalent Biotechnology training and 4+ years in the biotechnology workforce

Competencies

• Hands-on industry experience in the manufacture of GMP biologics, including mammalian cell culture, purification and/or drug product
• Experience working in a cleanroom environment with full clean room gowning 
• Highly self-motivated and detail-oriented, with proven ability to foster strong relationships with other team members and stakeholders
• Experience with single-use technology preferred
• Experience with visual inspection of drug product preferred

Working Conditions 

• Must be able to don cleanroom gowning and work in a manufacturing area
• Must be able to work alternative shift hours and weekends as required
• Must have flexible work hours, and be willing to work outside of normal, scheduled hours; as necessary.  Potential for 12 hour shifts, late nights, and weekend work as process demands. 
• Lifting requirements: Over 20 lbs
• Travel requirements: None

Discover True Collaborative Teamwork

We have an ambitious set of goals, but our confidence – and our inspiration – stems from our people. From California to North Carolina, our teammates bring a spirit of Collaboration, Leadership, and Innovation to their work every day.

We’re always looking for teammates with the drive and energy to help us grow. If you want to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, join us.

Kriya is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

All job requirements in the job description provided indicate the minimum level of knowledge, skills, and/or abilities deemed necessary to perform the job competently. Job descriptions are an overview of the duties, responsibilities, and requirements of the position. Employees may be required to perform other job-related assignments as requested.