28 days old

Manufacturing Associate

Baxalta U.S., Inc.
Thousand Oaks, CA 91362
  • Job Code
    R0071716
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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 following CGMP, environmental health and safety guidelines and any other related regulations. You will report to the Manufacturing Supervisor.

How you will contribute:

Cell Culture/Purification:

  • Support Cell Culture/Purification operations to produce a bulk drug substance product.
  • Prepare media and buffer solution.
  • Clean, oversee, 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.
  • Monitor and record important 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.
  • You will work in a team environment.
  • Provide feedback for operations and improve concerns.
  • Seek opportunities for personal development and monitor progress toward achieving development goals.
  • assist others in accomplishing work
  • General knowledge with cGMP manufacturing, regulatory regulations.
What you bring to Takeda:
  • High school diploma or equivalent required; Bachelor's degree preferred
  • 0-2 years of related work experience
What Takeda can offer you:
  • Comprehensive Healthcare: Medical, Dental, and Vision
  • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs and company match of charitable contributions
  • Family Planning Support
  • Professional development opportunities
  • Tuition reimbursement
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. You may:

  • The physical exertion of this role is medium to heavy work.
  • May require the use of special visual or auditory protective equipment.
  • May work at heights above floor level.
  • Will not operate foot controls or repetitive foot movement.
  • May work with dust, gasses, chemicals, liquid Nitrogen, and fumes. May require respiratory protection.
  • May sit between 1-2 hours.
  • May 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 walk or stand between 3-4 hours.
  • May bend at the neck/waist or squat for up to 1 hour in Bulk and between 1-2 hours in Suite A.
  • May reach above/below the shoulder between 1-2 hours
  • May twist at the waist up/twist at the neck up to 1 hour
  • May lift up to 75lbs in Bulk and over 75lbs in the Suite A area; Lifts per shift up to 14 times.
  • May carry up to 25lbs; Carry distance of up to 30ft; Carry 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 manage hazardous wastes in compliance with company procedures and State/Federal/Local hazardous waste regulations. Tasks 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).
  • May require overtime, weekend, and holiday work.
  • May work or be assigned to a different shift.
  • 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 artificial fingernails while in the manufacturing environment.
  • May work in a cold, hot, wet environment.
  • May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
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.

This posting excludes Colorado applicants.

#GMSGQ

#ZR1

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





Posted: 2022-07-15 Expires: 2022-08-13
Sponsored by:
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Sponsored by:
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Manufacturing Associate

Baxalta U.S., Inc.
Thousand Oaks, CA 91362

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