Manufacturing Associate I

Takeda Pharmaceuticals; Brooklyn Park (MN); On-site; USD 35,000 - 55,000; Full time

Job summary

Join a forward-thinking company as a Manufacturing Associate I, where you'll play a crucial role in ensuring the quality of biologics production. In this dynamic position, you'll operate advanced production equipment, perform essential manufacturing tasks, and maintain rigorous documentation standards in a cGMP environment. Your contributions will directly impact patient care and product quality. With a commitment to innovation and excellence, this role offers a unique opportunity to grow within a collaborative team dedicated to transforming patient care. If you are passionate about making a difference in the pharmaceutical industry, this is the perfect opportunity for you.

Qualifications

• High school diploma or GED required; Associates degree in a scientific discipline preferred.
• Experience in GMP environment and understanding of cGMP preferred.

Responsibilities

• Perform daily manufacturing operations according to SOPs in a cGMP environment.
• Operate biologics production equipment and document processing steps.

Skills

Basic computer operations

Mathematical calculations

Troubleshooting

Understanding of cGMP

Experience in GMP environment

Education

High school diploma or GED

Associates degree or higher in a scientific discipline

Tools

SAP

LIMS

Job description

Job Title: Manufacturing Associate I

Location: Brooklyn Park, MN

About the role:

As a Manufacturing Associate I, you will perform and document daily manufacturing operations according to SOPs in a cGMP environment. You will operate biologics production equipment (bioreactors, filtration units, chromatography systems and fixed/portable vessels) and will execute validation protocols. You will report to the Manufacturing Supervisor.

How you will contribute:

• Perform dispensing, labeling, and transferring/staging of raw materials and parts
• Assemble/disassemble, clean, and sterilize components, parts, and equipment
• Maintain equipment, area, and cleaning logbooks
• Assemble and operate biologics production equipment, such as bioreactors, filtration units, chromatography systems and fixed/portable vessels
• Perform basic troubleshooting
• Document cGMP data for processing steps and equipment activities while following standard operating procedures. Main documentation includes batch records, work orders, and equipment logbooks.
• Assist with processing steps and manufacturing support activities by managing process parameters in batch record and control systems.
• Execute batch records and validation protocols under management/direction of others.
• Review equipment use logs with support
• Perform inventory transactions in SAP
• Perform data entry into LIMS
• Perform cleaning/sanitizing production equipment

What you bring to Takeda:

• High school diploma or GED
• Experience in GMP environment preferred.
• Associates degree or higher in a scientific discipline preferred.
• Understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) preferred
• Knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management a plus
• Prior experience with lab equipment a plus
• Knowledge of mathematical calculations (addition, subtraction, division, multiplication) and rounding
• Basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Web Based Training (WBT)
• Familiarity or experience with cGMP within Biotech or Pharmaceutical operations a plus

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:

• Wear personal protective equipment (PPE) and other clean room garments daily.
• 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 that may require respiratory protection.
• Stand and walk while operating manufacturing/computer equipment for several hours daily.
• Carry, lift, push, and/or pull up to 50 pounds several times a day.
• Climb using stepladders/stairs in production areas several times a day.
• Bend, kneel, or crawl several times a day.
• Perform overhead reaching during handling of production materials several times a day.
• Move head and neck while using computer applications and handling production equipment.
• Twist waist while setting up equipment several times a day.
• Repetitive use of arms and wrists while setting up equipment several times a day.
• Must have the ability to work assigned shift (day or night).
• On rare occasions, travel may be required to offsite meetings or training events.

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.

Locations: Brooklyn Park, MN

Worker Type: Employee

Worker Sub-Type: Regular

Time Type: Full time

Job Exempt: No