Senior Manufacturing Associate

Job Description About the role

As a Senior Manufacturing Associate, you will perform manufacturing operations, including work functions in Cell Culture, Purification, Solution & Equipment Prep areas. You will operate production equipment according to SOPs for producing clinical and commercial products. Will support engineering and validation activities.

You will work on a 2-2-3 rotating shift with working hours from 6:00 AM to 6:30 PM.

• Troubleshoot and elevate process related issues
• Create work orders
• Initiate and document minor deviations
• Implement critical production operations
• Inform management of events improving 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
• Perform work in a safe manner, notifying management of safety issues
• Participate in tiered visual management system and support continuous improvement projects
• Initiate work orders
• Be a 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 and maintain compliant technical training for area personnel by developing/improving training materials and serving as a qualified trainer.

• Normally requires a 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.
• Biotech Certificate ideal
• Perform as a subject matter expert for equipment and systems
• Proficient in 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
• Experience with business systems such as LIMs, MODA and other business systems

• 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 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.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas.
• Ability to lift, pull, and 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.
• Stoop or bend to check or trouble‑shoot equipment operations.
• May require weekend or holiday off shift support
• Please be aware that this position is considered "Essential Personnel." This means that in the case of inclement weather (e.g. snow storm) the employee who occupies this position may be expected to report to work for their normal shift if management deems necessary. To ensure "Essential Personnel" are safe during inclement weather situations Shire may provide lodging, shuttle service, and food (depending on the severity and duration of the inclement weather event).
  
  These details will be provided by management prior to any potential inclement weather situation.

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…