Manufacturing Associate

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Job Title: Manufacturing Associate

Location: Thousand Oaks, CA

Under the general direction of the Manufacturing Lead and overall direction of the Supervisor, you will execute all processes in the production area while strictly following CGMP, environmental health and safety guidelines and any other related regulations.

You will work Sunday - Wednesday 6:00am - 4:30pm.

• Participate in bulk formulation, aseptic filling, lyophilization, and capping operations.
• Complete processes in production while strictly following cGMP, environmental health and safety guidelines and any other related regulations which could apply.
• Clean, set up, operate, and tear down equipment such as tanks, filtration systems, filling lines, lyophilizers, and more.
• Operate general production equipment such as an autoclave, filter integrity testers, temperature probes, pH and conductivity meters, CIP skids, and more. Gain qualification to perform CIP, SIP autoclave, small parts preparation.
• Receive and distribute supplies into the manufacturing areas.
• Identify processing gaps and help implement new technologies.
• Perform minor to moderate troubleshooting and manage tasks while paying attention to timelines and priorities. Provide feedback for operations and raise concerns.
• Draft simple to moderate DCRs and complete minor NCR investigations.
• Work in a team environment.
• May perform other duties as assigned.

• High school diploma or equivalent required; Bachelor's degree desirable.
• 0-2 years of related work experience.
• General knowledge with cGMP manufacturing, regulatory regulations and requirements desirable.

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.
• Be required to gown frequently and balance when gowning into clean areas.
• Be required to use special visual or auditory protective equipment.
• Be exposed to dust, gasses, chemicals, liquid Nitrogen, and fumes. May require respiratory protection.
• Be required to work in and have exposure to hot, cold, wet environment/conditions.
• Be required to work in confined areas; may be required to work around moving equipment and machinery.
• Be required to work at heights above floor level.
• Be required to sit between 1-2 hours.
• Be required to climb (use step stools and ladders) or kneel up to 1 hour.
• Be required to repetitive use of both right and left hands and arms up to 3-4 hours.
• Be required to walk, stand, or bend at the neck/waist for over 4 hours.
• Be required to squat between 1-2 hours.
• Be required to reach above/below the shoulder between 3-4 hours.
• Be required to twist at the waist up/twist at the neck up to 1 hour.
• Be required to lift up to 50lbs; Lifts per shift are up to 100 times.
• Be required to carry up to 50lbs; Carry distance of up to 6 feet; Carries per shift are up to 100 times.
• Require simple grasping and pushing/pulling with hands/arms between 3-4 hours; power grasping for over 4 hours; fine manipulation between 1-2 hours.
• Be required to work with biohazards such as: bloodborne pathogens or medical waste.
• Be required to enter a 2-8 degree Celsius and -60-degree Celsius freezer to store and retrieve materials and multiple chemicals to support manufacturing such as IPA, 500ppm sodium hypochlorite.
• Will need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
• Be required to manage hazardous waste in compliance with company procedures and State/Federal/Local hazardous waste regulations. Responsibilities 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 holidays.
• May require overtime and assignment to a different shift.

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.

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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:

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.