Manufacturing Associate

Role Summary

Manufacturing Associate at Takeda. Perform routine and critical manufacturing operations in Cell Culture, Purification, Solution & Equipment Prep areas, and operate production equipment according to SOPs for clinical and/or commercial products. Carry out cGMP manufacturing operations utilizing SOPs, Batch Records and Form Preps. Reports to Manufacturing Supervisor. This is a day shift role on a rotating 2-2-3 schedule.

Responsibilities

• Troubleshoot and resolve basic process related issues
• Recognize and escalate deviation
• Execute critical and routine activities in support of productions
• Perform batch record, log book and form prep requests
• Enter data in the Laboratory Information Management System (LIMS), MODA and other business functions
• Review GMP documentation
• Sample preparation and testing
• Identify changes needed for documentation
• Participate in tiered visual management system and support CI initiatives
• Complete required training
• Initiate work orders
• Assemble and disassemble process equipment
• Perform scheduled cleaning and standardization of equipment
• Support change over activities
• Execute equipment and process qualifications as well as validation
• Maintain training requirements
• Develop and maintain personal development plan
• Provide annual performance self-assessment on development plan

Qualifications

• Normally requires a high school diploma and 0 or more years of experience or an Associate's Degree in Life Sciences/Engineering field
• Biotech Certificate would be ideal
• Proficient at following written instruction in Batch Records, Form Preps, Technical Protocols and Procedures
• Proficient computer skills
• Full awareness of current Good Manufacturing Practices
• May be required to perform as a subject matter expert for equipment and/or systems
• Basic troubleshooting skills
• Proficient in aseptic technique

Skills

• Written instruction interpretation (Batch Records, Form Preps, Technical Protocols and Procedures)
• Electronic data entry and LIMS usage
• Aseptic technique
• Equipment setup, cleaning, and qualification

Education

• High school diploma required; Associate's Degree in Life Sciences/Engineering preferred
• Biotech certificate beneficial

Additional Requirements

• Work in a controlled environment with gowning and protective clothing; potential for protective equipment and hearing protection
• Cold, wet environment; stand for extended periods; lift/push/pull up to 25-50 lbs; climb ladders
• Ability to work multiple shifts including weekends; essential personnel in inclement weather may require reporting to work