Associate Manufacturing

• Perform and monitor critical manufacturing processes
• Execute routine validation protocols
• Comply with GMP requirements and all safety and compliance expectations
• Draft and revise routine documents such as MPs, SOPs, and technical reports
• Initiate and own quality records, including CAPA and CAPA-EV
• Identify and recommend improvements to routine functions and implement approved changes
• Perform basic troubleshooting and accurately recognize and report problems
• Direct operators on critical processes
• Assist in the review of documentation for assigned functions, including routine area audits and batch records
• Perform activities that may include rigorous and repetitive work
• Work around high-pressure systems and occasionally around heavy equipment
• Train staff on hands-on tasks, as needed
• Serve as a safety representative, as needed
• Participate on cross-functional teams and represent Manufacturing, as needed
• Apply technical, scientific, operational, and compliance knowledge to support implementation of new technologies into the plant
• Demonstrate strategic problem-solving skills and champion continuous improvement

High school diploma / GED and 2 years of manufacturing or operations work experience, or Associate degree and 6 months of manufacturing or operations work experience, or Bachelor's degree

• Bachelor's degree in science or engineering
• Knowledge of large-scale biotechnology operations such as purification, cell culture, and aseptic processing
• Knowledge of single-use systems
• CFR and regulatory knowledge
• Mechanical aptitude
• Basic statistical and mathematical skills
• Ability to interpret and apply GMP knowledge
• Understanding of analytical methods used in a manufacturing environment
• Demonstrated technical writing capability
• Project management and presentation skills
• Ability to understand, apply, and evaluate basic chemistry, biology, and physical principles
• Basic troubleshooting skills for production equipment
• Experience with Delta V
• Experience with lab equipment and testing

• Retirement and Savings Plan with generous company contributions
• group medical, dental and vision coverage
• life and disability insurance
• flexible spending accounts
• discretionary annual bonus program
• stock-based long-term incentives
• award-winning time-off plans
• flexible work models where possible