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Job Description

About the role:

The role is responsible for executing all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. In addition to being fully accountable and involved in all production processes, he/she may problem solve in other functional areas. The incumbent acts as a delegate to the supervisor and may conduct departmental activities in their absence. You will understand the regulations and may make recommendations according to their interpretations. You will be responsible for the successful transfer of new processes/methodologies into the manufacturing area.

How you will contribute:

• Assist supervisor in organizing, scheduling and directing other team members.
• Main interface with other departments to resolve issues related to equipment, process, compliance, including maintenance, metrology, and validation.
• Involved in hands-on execution of manufacturing operations.
• Ensure timely and accurate generation of process documentation. Review documentation.
• Resolve issues related to equipment, process and compliance.
• Main troubleshooting/response person.
• Investigate any process problems timely and provide documentation.
• Participate on Continuous Improvement Teams and may serve in a leadership role.
• Train and mentor other team members and monitor training for newer team members.
• Assist with process/equipment validation and data analysis
• Assign other project work and/or involvement in teams to team members.
• Represent the department in cross functional teams as necessary.
• May perform other duties as assigned.

What you bring to Takeda:

• Typically requires a high school diploma or GED plus 4+ years of related work degree or higher and 2+ years related work experience
• Knowledge of cGMP manufacturing and in-depth process knowledge of related manufacturing techniques/specialties.
• Thorough knowledge of laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment and CIP/SIP systems.
• Must be able to apply quantitative analysis to analyze process performance.
• Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.
• Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
• Good procedural writing skills.
• Knowledge of chemical and biological safety procedures.
• Good computer skills, knowledge of Microsoft Word and Excel.
• Must have demonstrated interpersonal and leadership skills and be able to lead a work team effectively and efficiently in a team environment.

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:

• Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Must be able to carry up to 25 lbs., lift up to 50 lbs., and push/pull > 100 lbs. (with the assistance of material handling equipment).
• Must be able to stand for extended periods of time over an entire 8 or 12-hour shift. Must be able to climb ladders and stairs while wearing special gowning.
• May require bending, twisting, reaching overhead, and/or squatting motions to perform certain tasks.
• Must be able to wo