Downstream Manufacturing Associate

Job Description About the role:

As a Downstream Manufacturing Associate, you’ll play a vital role in producing high-quality clinical and commercial products. Working under general supervision, you’ll perform routine and critical manufacturing activities across Cell Culture, Purification, and Solution & Equipment Preparation areas. You’ll 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 elevate 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 Associate’s 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 product. In 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.
• Stoopingorbendingtocheckortrouble-shootequipmentoperations.
• Ability to climb ladders and workplatforms.
• Ability to stand for 6 hours in a productionsuite.
• Abilitytolift,pullorpushequipmentrequiringupto
  25-50lbs.offorce.

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

We understand compensation is an important factor as you…