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Job Description

Job Title: Sr Manufacturing Associate
Location: Thousand Oaks, CA

About the role:

As a Sr. Manufacturing Associate, you will execute processes in the production area while strictly adhering to CGMP, environmental health and safety guidelines and any other related regulations. You will report to the Supervisor, Manufacturing.

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, 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.
• Set up operations, daily maintenance, and breakdown 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 moderate to complex troubleshooting.
• Draft complex DCRs and complete moderate NCR investigations.
• Rewrite complex procedures or initiate new procedures as applicable
• Demonstrate technical and administrative competence to organize and lead production activities, including leadership in state of the art cGMP compliance and EHS skills.
• Proficient with JD Edwards and understand how to issue materials to Manufacturing Work Orders, and account for the digital inventory of materials and review batch records. 
• Effectively collaborate with support groups and other manufacturing groups.
• Understand scheduled operations for up to one month in advance.  Provide insight to potential barriers and consistently provides feedback to remove barriers. 
• Lead the department through the manufacture of a product campaign.
• Demonstrate thorough theoretical knowledge background associated with areas performing.
• Develop training modules for new and current process lines.
• May perform other duties as assigned.

What you bring to Takeda:

• High school diploma required; bachelor’s degree preferred.
• 2+ years of related work experience
• Thorough knowledge of cGMP manufacturing, SOPs (standard operating procedures), regulatory regulations and requirements.
• Proficient at troubleshooting moderate to complex problems.
• Demonstrated ability to elevate issues effectively and apply appropriate corrections.

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 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 work and have exposure to hot, cold, wet environment/conditions.
• May be exposed to dust, gases, chemicals, liquid Nitrogen, and fumes which may require respiratory protection.
• May work in confined areas.
• 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.
• 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.
• Required to work an alternate work schedule (10-hour shift / 4 days a week) including weekends and possibly holidays.
• May require overtime and/or assignment to 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.

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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.

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