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Job Description
Job Title: Manufacturing Associate I Location: Thousand Oaks, CA
About the role:
Under the general direction of the Manufacturing Lead and overall direction of the Supervisor, the Manufacturing Associate I is responsible for executing 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:
Cell Culture/Purification:
Support Cell Culture/Purification operations for the production of 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 as necessary.
May perform other duties as assigned.
Formulation/Filling:
Participate in bulk formulation, aseptic filling, Lyophilization, and capping operations
Executes processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply
Clean, Set up, operate, and teardown of equipment such as, tanks, filtration systems, filling lines, lyophilizers, etc.
Operate general production equipment such as an autoclave, filter integrity testers, temperature probes, pH and conductivity meters, CIP skids, etc.
Receive and distribute supplies into the manufacturing areas.
May perform other duties as assigned.
All Areas
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 assist with implementation of new technologies.
Perform minor to moderation troubleshooting
Draft simple to moderate DCRs and complete minor NCR investigations.
What you bring to Takeda:
High school diploma or equivalent required; Bachelor’s degree preferred
0-2 years of related work experience.
Results oriented, self-motivated, and able to work independently
Able to work effectively and efficiently in a team environment.
Able to provide feedback for operations & elevate concerns as needed
Demonstrate initiative, proactiveness and effective communication
Actively seeks opportunities for personal growth and development and monitors progress toward achieving development goals.
Proactively assists others in accomplishing work
Listens carefully and is receptive to feedback from others.
General knowledge of CGMP and SOPs preferred
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 training and 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. In this role, you 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.
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.
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.
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.
