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Job Description

About the Role:

As Senior Manufacturing Associate, you will perform manufacturing operations, including 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. You will report to Manufacturing Supervisor.

How you will contribute:

• Perform cGMP manufacturing operations using SOPs, Batch Records, and Form Preps; troubleshoot and escalate process issues, execute production operations, and review documentation in real time to ensure compliance.
• Initiate and document minor deviations, create and request GMP documentation and work orders as needed.
• Enter data in systems such as LIMS, MODA, and other business tools; coordinate sample preparation and testing.
• Propose and review document revisions; inform management of events impacting schedules and escalate safety issues or risks.
• Participate in tiered visual management and support continuous improvement initiatives.
• Manage equipment and facility-related projects, including cleaning, assembly/disassembly, standardization, changeovers, and qualification/validation activities.
• Act as a subject matter expert on improvement projects and provide technical training; contribute to training material development and maintain training requirements.
• Develop and maintain a personal development plan, and complete an annual performance self-assessment.

What you bring to Takeda:

• 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 Certificate would be Ideal.
• 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/or systems
• You are proficient at following written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures.

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.
• Flexibility to work according to the production schedule.
• Ability to 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.
• Ability to work around chemicals (alcohols, acids & bases).

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

#GMSGQ #ZR1 #LI-MA1

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