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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, you will execute all processes in the production area while strictly adhering to CGMP, environmental health and safety guidelines and any other related regulations.
This is an on site position that works Sunday - Wednesday, 6:00am - 4:30pm.
How you will contribute:
- Participate in bulk formulation, aseptic filling, Lyophilization, and capping operations.
- Execute 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.
- 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.
- Gain qualification to perform CIP, SIP autoclave, small parts preparation.
- Identify processing gaps and assist with implementation of new technologies.
- Perform minor to moderate troubleshooting.
- Draft simple to moderate DCRs and complete minor NCR investigations.
- May perform other duties as assigned.
What you bring to Takeda:
- High school diploma or equivalent
- 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 be required to gown frequently and balance when gowning into clean areas.
- May require the use of special visual or auditory protective equipment.
- May be exposed to dust, gases, chemicals, liquid Nitrogen, and fumes. May require respiratory protection.
- May work and have exposure to hot, cold, wet environment/conditions.
- May be required to work in confined areas; may be required to work around moving equipment and machinery.
- May be required to work at heights above floor level.
- 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, stand, or bend at the neck/waist for over 4 hours
- May be required to squat between 1-2 hours
- May be required to reach above/below the shoulder between 3-4 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 50lbs; Lifts per shift are up to 100 times.
- May be required to carry up to 50lbs; Carry distance of up to 6 feet; Carries per shift are up to 100 times.
- May require simple grasping & pushing/pulling with hands/arms between 3-4 hours; power grasping for over 4 hours; fine manipulation between 1-2 hours.
- May be required to work with biohazards such as: bloodborne pathogens or medical waste.
- Will require entering a 2-8 degree Celsius & -60-degree Celsius freezer to store and retrieve materials and various chemicals in support of mfg such as IPA, 500ppm sodium hypochlorite.
- 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.
- 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.
- 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
#LI-Onsite
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 ConejoU.S. Hourly Wage Range:
$16.15 - $25.38The 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.
