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Takeda Pharmaceuticals

Thousand Oaks, CA

Sr Manufacturing Associate Jobs Near Me

Location235 N Moorpark Rd Ste A, Thousand Oaks, California 91360
Employment TypeContractor
Date Posted2022-08-07
Direct Apply
Valid Through2023-05-05

Job Description:

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Job Description

Job Title: Sr Manufacturing Associate

Location: Thousand Oaks, CA

About the role:

Under the general direction of the Manufacturing Lead and the direction of the Supervisor, the Sr 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:

  • Support Cell Culture/Purification operations to produce a bulk drug substance product.

  • Prepare media and buffer solution. Perform sampling using aseptic techniques.

  • Clean, oversee, and teardown of equipment such as tanks, filtration systems, carton assembler, bioreactors, and production lines.

  • Gain qualification to perform CIP, SIP autoclave, small parts preparation.

  • Operate general production equipment (such as pH and conductivity meters, autoclave, portable mixers).

  • Perform routine maintenance and cleaning of production equipment to maintain equipment in GMP fashion.

  • Perform moderate troubleshooting. Monitor and record important process parameters.

  • Identify processing gaps and help implement new technologies.

  • Receive and distribute supplies into production area.

  • Complete relevant paperwork following GDP/GMP guidelines.

  • Draft complex DCRs and complete moderate NCR investigations.

  • Rewrite complex procedures or initiate new procedures as applicable.

  • Develop training modules for new and current process lines.

  • Demonstrate technical and administrative competence to organize and lead production activities, including leadership in CGMP compliance and EHS skills.

  • Proficient in JDE and understand how to issue materials to Manufacturing Work Orders, and account for the digital inventory of materials and review batch records.

  • collaborate with support groups and other manufacturing groups.

  • You will understand scheduled operations for up to one month in advance. Provide insight to potential barriers and provide feedback to remove barriers. May attend periodic planning meeting as a department representative

  • Lead the department through the manufacture of a product campaign. Provide oversight to the department.

  • Demonstrate theoretical knowledge background associated with areas they are performing.

  • Seek opportunities for personal development and monitors progress toward achieving development goals.

  • Assist others in accomplishing work.

  • Knowledge of CGMP manufacturing, SOPs (standard operating procedures), regulatory regulations.

  • Proficient at troubleshooting moderate to complex problems.

  • You will work in a team environment.

  • You will provide feedback for operations and improve concerns.

What you bring to Takeda:

  • High school diploma required; Bachelor's Degree.

  • 2- 4 years of related work experience

Internal Candidates: Minimum 1-year experience. Must demonstrate the proficiencies, qualifications, and behaviors to qualify for the position.

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 is medium to heavy work.

  • May be required to gown frequently and balance when gowning into clean areas.

  • May require the use of special visual or auditory protective equipment.

  • May work at heights above floor level.

  • 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.

  • 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; Lift per shift up to 14 times.

  • May carry up to 25lbs; Carry distance of up to 30ft; Carry per shift up to 6 times.

  • 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.

  • 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.

  • 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 / conditions.

  • May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

  • May work with dust, gasses, chemicals, liquid Nitrogen, and fumes. May require respiratory protection.

  • May work in confined areas; may work around moving equipment and machinery

  • May require office work activities between 1-2 hours.

  • Required to work 4 days a week, 10-hour days. We ask that you work weekend work (Sat or Sun).

  • May work overtime, holidays, or be assigned to a different shift.

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 to 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.


USA - CA - Thousand Oaks - Rancho Conejo

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Job ID: 3778899984894600766

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