Manufacturing Associate

Takeda Pharmaceutical Company • Lexington, MA

399d • $39,208 - $61,610

About The Position

As a Manufacturing Associate at Takeda Pharmaceutical, you will be responsible for performing routine and critical manufacturing operations in areas such as Cell Culture, Purification, and Equipment Preparation. This role involves operating production equipment according to Standard Operating Procedures (SOPs) to produce clinical and commercial products, while ensuring compliance with Good Manufacturing Practices (cGMP). You will report directly to the Manufacturing Supervisor and contribute to the overall production goals of the department.

Requirements

• High school diploma or GED with 0-4 years related industry experience, or an Associate's Degree in Life Sciences/Engineering field.
• Experience with general aspects of the job and a broad understanding of detailed aspects.
• Proficient in Aseptic Technique and full awareness of current Good Manufacturing Practices.
• Ability to follow written instructions in the form of Batch Records, Form Preps, and Technical Protocols.
• Ability to work cohesively in a team environment.

Nice To Haves

• Biotech Certificate would be ideal.
• Experience as a subject matter expert for equipment and/or systems.

Responsibilities

• Troubleshoot and resolve basic process-related issues.
• Accomplish cGMP manufacturing operations using SOPs, Batch Records, and Form Preps.
• Recognize and escalate deviations in processes.
• Implement critical and routine activities to support production.
• Perform Batch Record, Log Book, and Form Prep requests.
• Enter data in the Laboratory Information Management System (LIMS) and other departments.
• Review GMP documentation and perform sample preparation and testing.
• Identify changes needed to documentation and participate in tiered visual management systems.
• Initiate work orders and perform assembly and disassembly of process equipment.
• Conduct scheduled cleaning and standardization of equipment.
• Support changeover activities and implement equipment and process qualifications and validation.
• Maintain training requirements and develop a personal development plan.
• Provide annual performance self-assessment on development plan.
• Work on moderately complex assignments requiring judgment in problem resolution.
• Evaluate and elevate issues to senior staff.

Benefits

• Paid holidays
• Disability insurance
• Health insurance
• Dental insurance
• Tuition reimbursement
• Paid time off
• Vision insurance
• 401(k) matching
• Volunteer time off
• Life insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: High school or GED