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Job Description

Job Title: Manufacturing Associate III

Location:  Brooklyn Park, MN

About the role:

As the Manufacturing Associate III, 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 create/revise cGMP procedures and will be responsible for training less experienced or new manufacturing associates. You will report to the Manufacturing Supervisor.

How you will contribute:

• Independently assemble and/or operate biologics production equipment, such as bioreactors, filtration units, chromatography systems, and fixed/portable vessels while observing all cGMP requirements.
• Participate in cross functional projects teams, support technical transfers with relevant teams/individuals
• Support deviation investigations by completing deviation intake documentation.
• Perform complex trouble shooting and root cause analysis. May participate in resolving issues regarding operations.
• Document cGMP data and information for processing steps and/or equipment activities while following standard operating procedures. Key documentation includes batch records, work orders, and equipment logbooks.
• Independently perform/or assists with processing steps and/or manufacturing support activities by monitoring process parameters in batch record and control systems.
• Able to execute batch records and validation protocols independently.
• Author and review equipment use logs.
• Performs data entry into LIMS, SAP and coordinate sample delivery.
• Perform cleaning/sanitizing production equipment.
• Monitor complex to critical processes and identify if there is a deviation. May support and/or complete deviation investigations.
• Author and/or Review SOP and Batch Record revision and author change requests
• Participate in cross functional project teams and support technical transfers with relevant teams/individuals.  
• Complete Batch Record review and assists with BR closure.
• Revise and/or create new manufacturing procedures.
• Apply technical knowledge to perform complex trouble shooting tasks and participate in departmental projects.
• Provides suggestions/ideas for corrective actions (CA) and preventative actions (PA) for non-conformances and/or safety events.
• Identify and recommend continuous improvements related to routine functions and implement after approval.
• Assist in incident/non-conformance generation and resolution.

What you bring to Takeda:

• High school diploma or GED
• 3+ years experience in a GMP environment
• Associates degree or higher in a scientific discipline would be ideal.
• Experience with systems such as SAP, LIMS, Trackwise would be ideal.
• Proficient at following written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures
• Demonstrated application of current Good Manufacturing Practices (cGMP’s) and Good Documentation Practice (GDP).
• Knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management.
• Prior experience with lab equipment, computers, and intermediate mathematical skills.
• Knowledge of mathematical calculations (addition, subtraction, division, multiplication) and rounding.
• Ability to perform basic computer operations, such as ability to navigate in MS Office, use email, and complete training using Web Based Training (WBT).
• Experience with cGMP Biotech or Pharmaceutical operations.
• Mechanical ability/expertise; including understanding equipment function and application.
• Proficient and knowledgeable in the operation of two manufacturing areas or processes (i.e., downstream, upstream, media buffer, deviation writing).
• Possess equipment understanding, including understanding equipment function and application.

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:

• May be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
• 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.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Stand and Walk - Required to stand/walk while operating manufacturing/computer equipment for several hours at a time daily
• Carry weight, Pushing, Pulling Lifting - Required to carry, lift, push, and/or pull up to 50 pounds several times a day for 15-minute durations while handling production equipment and/or materials
• Climb - Required to climb (use of stepladders/stairs in production areas, or stairwells in work campus) several times a day for 15-minute durations
• Bend and Kneel - Required to bend, kneel, or crawl several times a day for 15-minute durations
• Overhead work - Required to perform overhead reaching during handling of production materials/files/supplies several times a day for 15-minute durations
• Move Head and Neck – Required movement of head/neck while using computer applications and handling of production equipment and materials several times a day for several hours at a time
• Twisting - Required movement of twisting waist while setting up equipment several times a day for several hours at a time
• Repetitive Use - Required repetitive use of arms and wrists while setting up equipment several times a day for several hours at a time.
• Must have the ability to work assigned shift (day or night)

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.

#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 job. 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.

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