Top 3 Must Have Skill Sets:
Comprehension and compliance with GMP practices (1-3 years of experience)
Manufacturing experience / supply chain experience (1-3 years of experience)
Troubleshooting equipment (1-3 years of experience)
** Work schedule: 6:30 PM-7:00 AM. Workdays rotate every 2 weeks (week 1: Mon, Tue, Fri, Sat, Sun week 2: Wed, Thur). This schedule repeats every two weeks. Expected to work holidays if they fall on scheduled shift. MUST BE RELIABLE ***
***working on site during COVID-19***
Under general supervision, Associate will perform operations in the Manufacturing area. Operations will be performed according to Standard Operating Procedures (SOPs). Associate will perform and monitor critical processes, execute routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports. Employee will also perform basic troubleshooting and assist in the review of documentation for assigned functions. May participate on cross-functional teams and represent their functional area (Cell Culture, Purification, or Solution Preparation). Employee may also have the responsibility of owning deviation/CAPA records. In addition, employee may identify, recommend, and implement improvements related to routine functions.
• Bachelor's degree or completed by Dec 2020
• Associate's degree and 4 years of Manufacturing or Operations experience
• High School diploma/GED and 6 years of Manufacturing or Operations experience.
• Knowledge of large-scale biotechnology operations such as purification, cell culture, aseptic processing, etc.
• CFR and Regulatory knowledge
• Mechanical ability/expertise
• Basic statistical mathematical skills
• Ability to interpret and apply GMP knowledge
• Understanding of analytical methods for manufacturing area
• Ability to demonstrate technical writing capability
• Able to demonstrate project management skills and presentation skills
• Ability to understand, apply and evaluate basic chemistry, biology and physical principles
• Basic troubleshooting skills on production equipment
• Experience with Delta V
• Experience with lab equipment/testing
This position is a 12.5hr/day rotating schedule from 6:30am to 7:00pm working every other weekend. This includes working holidays and in inclement weather.