Base: $50,000.00 - $65,000.00; bonus/equity: not s...
Cgmp compliance and regulatory adherence
Aseptic technique in cleanroom environment
Environmental monitoring and particle counts
The primary mission is to manufacture cell-based products and clinical grade reagents for Phase I, II, and III clinical trials while adhering to strict FDA regulations
Job Summary
The primary mission is to manufacture cell-based products and clinical grade reagents for Phase I, II, and III clinical trials while adhering to strict FDA regulations.
The role requires performing routine assignments related to documentation, environmental monitoring, and aseptic preparation of cellular infusion procedures under G'X'P guidelines.
Candidates must be self-starters capable of maintaining strict compliance with federal regulations and detailed record keeping while working collaboratively within a team atmosphere.
Matching Summary
The primary mission is to manufacture cell-based products and clinical grade reagents for Phase I, II, and III clinical trials while adhering to strict FDA regulations.
Salary
Base: $50,000.00 - $65,000.00; Bonus/Equity: Not specified; Benefits: Health, retirement, and paid time off included
Skills & Requirements
Must-have
cGMP compliance and regulatory adherence
Aseptic technique in cleanroom environment
Environmental monitoring and particle counts
Equipment qualification IQ OQ PQ
Batch record documentation and SOP execution
Nice-to-have
Ability to work off hours and weekends
Experience with Oracle purchasing system
Strong interpersonal communication skills
Capacity to manage competing priorities
Proficiency in Microsoft Office Suite
Key Requirements
College or university degree in related field
Less than 2 years of work experience minimum
Bachelor's degree in biology or related field preferred
2-3 years post-bachelor laboratory experience preferred
Prior experience in cell culture or molecular biology desirable