Principal Research Associate, Quality Control

Rochester, New York
Nov 25, 2021
NextGen Bio
Required Education
Bachelors Degree
Position Type
Full time

About the role

Sana Biotechnology is growing, and we are hiring new team members who believe in the potential of engineered cells as medicines, who want to challenge status quo, and who lead with the desire to work on novel ideas. As a Principal Research Associate, you will report to the Head of Quality Control to support Quality Control, specifically Environmental Monitor for the Rochester, NY cell therapy and gene therapy manufacturing site/team. Cool stuff.

What you'll do

  • You will support environmental monitoring testing which will include sampling, testing and shipment of samples to contract third-party test sites. You will review test results to allow release of manufacturing suites for production. The testing scope could expand at a later time to include in-process and release testing
  • You will help maintain QC labs
  • You will participate in the writing and review of Quality Control SOPs, method validation protocols and reports
  • You will participate in establishment of method suitability-for-use or method validation for in-house testing and equipment

What we're looking for

  • Bachelor's plus 6 yrs or MS with 4+ yrs or equivalent combination of education and work experience
  • Experienced in environmental monitoring. You will lead the environmental monitoring program at the Rochester GMP manufacturing facility and design practical solutions to resolve EM QC issues
  • You are familiar with quality processes such as change control, discrepancy/CAPA owner and GMP Quality Systems such as: TrackWise, LIMS, DMS

What will separate you from the crowd

  • You are experienced in environmental monitoring and quality control processes

What you should know

  • 10-20% travel may be required
  • Lab work is required at both lab bench and biosafety cabinet
  • Some lifting of consumables required
  • Working safely in person on a predictable and regular basis is an essential job responsibility for this position and we require that all individuals working in-person, subject to certain exceptions, be fully vaccinated against COVID-19

How we work together

  • Lead from every seat – we seek to understand, act with honesty, and engage in the crucial conversations
  • Thrive as a team – we hire amazing people, are intensely curious, and cultivate inclusion and personal connectivity
  • Make it happen – we value vigorous debate, alignment around our decisions, and resilient execution

Get to know us

At Sana, we believe that a diverse workforce strengthens us as a company and helps us to achieve our mission to meaningfully change the outcome of many human diseases. This belief is a pillar of our business and is critical to our success. Our goal is that Sana is the place for talented people to bring their authentic selves to work, to have a great career and to deeply, positively impact patients.

Core to our values, we believe there is nothing more important than the health and wellness of you and your family. For benefit eligible employees, we cover 100% of the cost for employee health coverage and offer generous time-off, parental leave, short- and long-term disability, financial wellness programs, a 401(k) Plan, Employee Stock Purchase Plan, commuter subsidy and a variety of wellness offerings to support each person individually.

We are committed to providing a workplace free of discrimination and harassment based on race, color, religion, age, gender, national origin, ancestry, physical or mental or sensory disability (including the use of a trained guide dog or service animal by a person with a disability), genetic information, actual or perceived HIV or Hepatitis C infection, medical condition (cancer or a record or history of cancer and genetic characteristics), marital status, sexual orientation, sexual preference, pregnancy (including childbirth and related medical conditions), disability, veteran status, political ideology, taking or requesting statutorily protected leave, status as a victim of domestic violence, sexual assault or stalking, or any other basis prohibited by applicable law.

To perform this job successfully, you must be able to perform each job responsibility satisfactorily. The job description listed above is representative of the knowledge, skills, and/or abilities required for this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions described above.