Genezen Manufacturing Specialist

7 days ago


Lexington, Kentucky, United States Genezen Full time
About Genezen

At Genezen, we are dedicated to delivering cutting-edge solutions in the field of gene therapy. Our team is passionate about empowering employees to be innovative problem solvers who drive our company's success.

Job Summary

This role will focus on performing routine and non-routine manufacturing operations, ensuring compliance with cGMP quality standards and Standard Operating Procedures (SOPs). The successful candidate will have a strong foundation in process-oriented thinking and a commitment to excellence.

Key Responsibilities
  • Manufacturing Operations: Perform daily morning meetings, weekly/monthly walkthroughs, and ensure safe and compliant working environments.
  • Process Management: Troubleshoot issues according to SOPs, execute production operations according to MFG schedules, and document activities in Batch Production Records (BPR), Solution records (SLR), Logbooks, and Forms.
  • Equipment Maintenance: Schedule cleaning of equipment, assemble/disassemble process equipment, standardize equipment, and support equipment qualifications if needed.
Requirements

To succeed in this role, you will need:

  • Education: High School Diploma or Associate's degree in Life Sciences/Engineering field with 1 year of cGMP Manufacturing experience.
  • Experience: 1+ years of relevant cleanroom GMP industry experience.
  • Skills: Ability to work within standard operating procedures, scientific method, and adhere to company internal and regulatory policies.
  • Physical Demands: Frequent standing, sitting, walking, balancing, stooping, kneeling, crouching, and lifting up to 40lbs.
Benefits
  • Paid vacation days, amount based on tenure.
  • Paid sick time.
  • 9 observed holidays + 1 floating holiday + 1 volunteer day.
  • 401(k) plan with company match up to 6% of salary, vested immediately.
  • Choice of several healthcare plans.
  • FSA and HSA programs.
  • Dental & vision care.
About the Location

Genezen operates two locations: Fishers, Indiana, and Lexington, Massachusetts. Both cities offer a unique blend of history, culture, and community pride, making them ideal places to live and work.



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