Senior Manufacturing Associate

Takeda Pharmaceutical Company • Lexington, MA

109d • $18 - $29

About The Position

As a Senior Manufacturing Associate, you will perform manufacturing operations, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operates production equipment according to SOPs for the production of clinical and/or commercial products. Will support engineering and validation activities.

Requirements

• Normally requires a high school diploma and 4+ years of experience or an associate's degree in Life Sciences/Engineering field with 3 years of GMP Manufacturing experience.
• Biotech certification preferred.
• Proficient at following written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures.
• Possess excellent communication and troubleshooting skills.
• Full awareness of current Good Manufacturing Practices.
• Proficient computer skills.
• Proficient in Aseptic Technique.
• Work cohesively in a team environment.
• Experience with business systems such as LIMS, MODA and other business systems.
• Clear understanding of manufacturing processes and the ability to readily identify deviations in process, controls, and guidelines required.

Responsibilities

• Perform cGMP manufacturing operations.
• Follow Standard Operating Procedures (SOP), Batch Records and Form.
• Troubleshoot and escalate process related issues.
• Create work orders.
• Initiate and document minor deviations.
• Execute critical, routine and non-routine production operations.
• Inform management of events impacting schedule request and execution of GMP documentation.
• Enter data in the Laboratory Information Management System (LIMS), MODA and other business systems.
• Review manufacturing documentation real time to ensure compliance.
• Coordinate sample preparation and testing.
• Propose and review document revisions.
• Carry out work in a safe manner, notifying management of safety issues and risks.
• Participate in tiered visual management system and support continuous improvement initiatives.
• Act as subject matter expert for improvement projects.
• Perform scheduled cleaning of equipment.
• Assembly and disassembly of process equipment.
• Perform standardization of equipment.
• Support change over activities.
• Build equipment and process qualifications and validation.
• Provide technical training for area personnel.
• Contribute to training material development.
• Maintain training requirements and act as a qualified trainer as required.
• Develop and maintain personal development plan.
• Provide annual performance self-assessment.

Benefits

• Medical, dental, vision insurance.
• 401(k) plan and company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off.
• Company holidays.
• Well-being benefits.
• Up to 80 hours of sick time per calendar year.
• Accrual of up to 120 hours of paid vacation for new hires.

What This Job Offers

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