Manufacturing Technician

Responsibilities

• Carry out cGMP manufacturing operations utilizing SOPs, Batch Production Records, and Solution prep records
• Perform routine and non-routine production operations in Cell Culture, Purification, and Solution & Equipment Prep areas
• Document operations according to GDP principles in BPRs, SLRs, Logbooks, and Forms
• Maintain process area orderliness and stock production supplies
• Perform scheduled equipment cleaning, standardization, and support product changeovers
• Execute troubleshooting activities and support equipment/process qualifications
• Attend daily shift hand-off meetings and ensure information sharing

Requirements

• High school diploma with 2-4 years of related cGMP industry experience, OR an Associate’s Degree in Life Sciences/Engineering with 1 year of cGMP experience
• Experience in (bio)-manufacturing unit operations (USP and/or DSP)
• Hands-on experience writing and reviewing documentation
• Ability to adhere to EMA and FDA regulatory policies
• Ability to lift up to 40lbs
• Proficiency in aseptic techniques

Preferred Qualifications

• Bachelor’s Degree in Life Sciences or Engineering
• Previous experience in a comparable industrial organization

Benefits

• Paid vacation and sick time
• 10 observed holidays plus 2 floating holidays and 1 volunteer day
• 401(k) plan with company match up to 6%
• Share Appreciation Rights
• Healthcare, dental, and vision plans
• FSA and HSA programs
• Employer-paid basic term life and personal accident insurance

About the Company

Genezen provides process development, produces GMP viral vectors, and provides cell transduction for gene and cell therapy clinical trials to help lead to new cures.