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Job Description

Job Title: Senior Manufacturing Associate

Location: Lexington, MA

About the role:

You will report to the Manufacturing Supervisor and perform routine manufacturing operations, including work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operate production equipment according to SOPs for producing clinical and commercial products. Will support engineering and validation activities.

How you will contribute:

You will manage cGMP manufacturing operations using Standard Operating Procedures (SOP), Batch Records and Form Preps. Responsibilities include :

• Troubleshoot and escalate process related issues
• Create work orders
• Initiate and document minor deviations
• Implement critical, routine production operations
• 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
• Participate in tiered visual management system and support continuous improvement initiatives
• Perform scheduled cleaning of equipment
• Assembly and disassembly of process equipment
• Perform standardization of equipment

What you bring to Takeda:

• High school diploma and 4-6 years related industry experience or an Associate's Degree in Life Sciences/Engineering field with 3 years of GMP Manufacturing experience.

Key Skills, Abilities and Competencies

Experience with the general and detailed aspects of the job, and their practical applications to problems and situations ordinarily encountered.

• Will perform as a subject matter expert for equipment and systems
• You are proficient at following written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures.
• Full awareness of current Good Manufacturing Practices..
• Proficient in Aseptic Technique
• Provide technical training for area personnel
• Maintain training requirements and act as a qualified trainer
• Maintain personal development plan
• Provide annual performance self-assessment
• Work cohesively in a team environment
• Experience with business systems such as, LIMs, MODA and other business systems
• Will work holidays and overtime as required.
• May be required to adjust work schedule to meet production demands.
• Proficient in Aseptic Technique
• Wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes.
• Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas.
• Lift, pull or push equipment requiring up to 25-50 lbs. of force.
• Ability to stand for 6 hours in a production suite.
• Ability to climb ladders and work platforms.
• Stooping or bending to check or trouble-shoot equipment operations.
• Work around chemicals (alcohols, acids & bases).

Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:

• May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and heari