Downstream Manufacturing Associate

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As a Downstream Manufacturing Associate youll play a vital role in producing high-quality clinical and commercial products. Working under general supervision youll perform routine and critical manufacturing activities across Cell Culture Purification and Solution & Equipment Preparation areas. Youll operate production equipment in accordance with established SOPs ensuring safe compliant and efficient execution of manufacturing processes.

• Perform cGMP manufacturing operations in accordance with SOPs batch records and form preparations.
• Execute routine and critical production activities safely and accurately.
• Troubleshoot basic process issues and escalate deviations appropriately.
• Complete batch records logbooks and form preparation requests.
• Enter and maintain accurate data in LIMS MODA and other business systems.
• Review GMP documentation and identify required updates or improvements.
• Prepare and test samples as required.
• Initiate work orders and perform equipment assembly disassembly cleaning standardization and changeovers.
• Support equipment and process qualifications validation activities continuous improvement initiatives and tiered visual management.
• Complete required training on time maintain a personal development plan and provide an annual performance self-assessment.

• Normally requires a high school diploma and 0-4 years related industry experience or an Associates Degree in Life Sciences/Engineering field.
• Biotech Certificate preferred

• Proficient in Aseptic Technique

• May be required to perform as a subject matter expert for equipment and/or systems
• 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

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 this role you may:

• 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.
• 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.

• Stooping or bending to check or trouble-shoot equipment operations.

• Ability to climb ladders and work platforms.

• Ability to stand for 6 hours in a production suite.

• Ability to lift pull or push equipment requiring up to 25-50 lbs. of force.

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

Takeda Compensation and Benefits Summary

For Location:

U.S. Hourly Wage Range:

The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors including the qualifications of the individual applicant for the position years of relevant experience specific and unique skills level of education attained certifications or other professional licenses held and the location in which the applicant lives and/or from which they will be performing the actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical dental vision insurance a 401(k) plan and company match short-term and long-term disability coverage basic life insurance a tuition reimbursement program paid volunteer time off company holidays and well-being benefits among others. U.S. based employees are also eligible to receive per calendar year up to 80 hours of sick time and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race color religion sex sexual orientation gender identity gender expression parental status national origin age disability citizenship status genetic information or characteristics marital status status as a Vietnam era veteran special disabled veteran or other protected veteran in accordance with applicable federal state and local laws and any other characteristic protected by law.

Job Exempt