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Job Description

About the role:

As a Senior Manufacturing Associate, you will perform routine and non routine 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. You will report to Manufacturing Supervisor.

This is a night shift role, with working hours from 6:00 p.m. to 6:00 a.m. on a rotating 2-2-3 schedule, which includes working every other weekend.

How you will contribute:

• Carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Records and form preps.
• Troubleshoot and escalate process related issues; create work orders as needed; initiate and document minor deviations; initiating work orders.
• Enter data in the Laboratory Information Management System (LIMS), MODA and other business systems; request and execution of GMP documentation.
• Lead execution of critical, routine and non-routine production operations; inform management of events impacting schedule; review manufacturing documentation real time to ensure compliance.
• Coordinate sample preparation and testing; propose and review document revisions; perform scheduled cleaning of equipment.
• 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.
• Assembly and disassembly of process equipment; perform standardization of equipment; support change over activities; execution of equipment and process qualifications and validation.
• Act as subject matter expert for improvement projects; will be required to perform as a subject matter expert for equipment and/or systems; provide technical training for area personnel; provide input on 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.

What you bring to Takeda:

• 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.
• Substantial understanding of the general and detailed aspects of the job, and their practical applications to problems and situations ordinarily encountered
• The individual is 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 computer skills.
• Proficient in Aseptic Technique
• Work cohesively in a team environment
• Experience with business systems such as, LIMs, MODA and other business systems

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.
• Will work holidays and overtime as required.
• May be required to adjust work schedule to meet production demands.
• Proficient in Aseptic Technique
• Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes.
• Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas.
• Ability to lift, pull or push equipment requiring up to 25-50 lbs. of force.