Manufacturing Associate - Day - Thousand Oaks California

Company: Takeda
Location: Thousand Oaks, California
Posted On: 04/15/2024

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Job Description

Job Title: Manufacturing Associate

Location: Thousand Oaks, CA

About the role:

Under the general direction of the Manufacturing Lead and overall direction of the Supervisor, the Manufacturing Associate executes all processes in the production area while strictly adhering to CGMP, environmental health and safety guidelines and any other related regulations.

How you will contribute:

• Support Cell Culture/Purification operations to produce a bulk drug substance product.
• Prepare media and buffer solution.
• Clean, set up, operate, and teardown of equipment such as tanks, filtration systems, carton assembler, bioreactors, and production lines.
• Operate general production equipment (such as pH and conductivity meters, autoclave, portable mixers, etc.).
• Monitor and record critical process parameters.
• Complete relevant paperwork following GDP/GMP guidelines.
• Perform routine maintenance and cleaning of production equipment to maintain equipment in GMP fashion.
• Manually clean portable equipment and small parts.
• Perform sampling using aseptic techniques.
• Participate on Continuous Improvement Teams.
• Receive and distribute supplies into production area.
• Set up operations, daily maintenance, and break down of simple/routine equipment.
• Gain qualification to perform CIP, SIP autoclave, small parts preparation.
• Identify processing gaps and help implement new technologies.
• Perform minor to moderate troubleshooting.
• Draft simple to moderate DCRs and complete minor NCR investigations.
• Able to provide feedback for operations & elevate concerns as needed.
• Actively seeks opportunities for personal development and monitors progress toward achieving development goals.
• General knowledge with cGMP manufacturing, regulatory regulations is preferred.
  
  What you bring to Takeda:
  
  
  • High school diploma or equivalent required; bachelor's degree preferred.
  • 0-2 years of related work experience
    
    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:
    
    • The overall physical exertion of this position requires medium to heavy work.
    • May require the use of special visual or auditory protective equipment.
    • May be required to work at heights above floor level.
    • Will not be required to operate foot controls or repetitive foot movement.
    • May work and have exposure to hot, cold, wet environment/conditions.
    • May be required to sit between 1-2 hours.
    • May be required to climb (use step stools and ladders) or kneel up to 1 hour.
    • Requires repetitive use of both right and left hands and arms up to 3-4 hours.
    • May be required to walk or stand between 3-4 hours.
    • May be required to bend at the neck/waist or squat for up to 1 hour in Bulk and between 1-2 hours in Suite A.
    • May be required to reach above/below the shoulder between 1-2 hours.
    • May be required to twist at the waist up/twist at the neck up to 1 hour.
    • May be required to lift up to 75lbs in Bulk and over 75lbs in the Suite A area; Lifts per shift up to 14 times.
    • May be required to carry up to 25lbs; Carry distance of up to 30ft; Carries per shift up to 6 times in Bulk and up to 14 times in Suite A.
    • May require simple grasping/power grasping and fine manipulation up to 1 hour.
    • May require pushing/pulling with hands/arms between 1-2 hours.
    • May require office work activities with hands/arms up to 1 hour in Bulk; between 1-2 hours in Suite A.
    • May 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.
    • Will need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
    • May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
    • May be required to manage hazardous waste in compliance with company procedures & State/Federal/Local hazardous waste regulations. Duties may include identifying, handling, generating, accumulating, storing, labeling, and on-site transporting of hazardous wastes.
    • Required to work an alternate work schedule (10-hour shift / 4 days a week) including a weekend day and possibly holidays.
    • May require overtime and/or assignment to a different shift as needed.
      
      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
      
      Takeda Compensation and Benefits Summary
      
      We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
      
      For Location:
      USA - CA - Thousand Oaks - Rancho Conejo
      
      U.S. Hourly Wage Range:
      $16.15 - $25.38
      
      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 e mployee s may be eligible for s hort - t erm 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.
      
      Locations
      
      USA - CA - Thousand Oaks - Rancho Conejo
      
      Worker Type
      
      Employee
      
      Worker Sub-Type
      
      Regular
      
      Time Type
      
      Full time More...

          

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