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Job Description

About the Role:

The Manufacturing Lead Operator executes processes in production while strictly following cGMP, environmental health and safety guidelines and any other related regulations which could apply. Under the overall direction of the supervisor, this person must aid in establishing daily shift priorities, and then communicate and delegate tasks to safely accomplish those priorities. They are expected to make Safety, Quality, and Production decisions. You can apply their subject matter expertise and their understanding of the capabilities and performance of their team members to quickly assess critical issues. You can escalate all relevant information and be prepared to recommend appropriate actions. They are expected to report all critical information to their respective teams and be able to communicate the appropriate shift-to-shift updates through all applicable communication tools and at shift handoffs. In addition to being accountable in production processes, you may help in other teams. They are expected to fully participate in both departmental projects and quality working teams. You will be a delegate to the supervisor and may conduct departmental activities in their absence. They understand the regulations and may make recommendations according to their interpretations. They have a high level of technical and administrative knowledge to perform complex troubleshooting tasks on manual and automated equipment, and they may assist during the transfer of new processes/methodologies into the manufacturing area. Manufacturing Lead Operators are expected to serve as a mentor and set the example for all team members since their team will interpret that behavior as acceptable. They must display the appropriate conduct, compliance, cleanliness, and culture while promoting Takeda's focus on Patient, Reputation, and Business

How you will contribute:

• Follow all safety rules, SOPs, cGMP, work rules and other company policies and initiatives.
• Complete relevant paperwork following GDP/GMP guidelines.
• Perform hands-on execution of manual and automated manufacturing operations. Equipment may include: Centrifuges, Filter Presses, Ultrafiltration, Tangential Flow Filtration and Nanofiltration systems, CIP/COP, Chromatography and material handling devices. Manual activities include weighing and addition of chemicals, paste suspension, equipment cleaning, room cleaning, equipment assembly/disassembly, transfer panel connections, titrations and other activities.
• Receive and distribute supplies into the production area as necessary.
• Perform removal of hazardous waste.
• Troubleshoot process problems and respond to process alarms.
• Act as the primary manufacturing personnel to resolve and communicate issues related to safety, quality, compliance and process to the supervisor. Main interface with other departments including maintenance, metrology, engineering and validation.
• Assist supervisor in organizing, scheduling, and directing other team members.
• May act as a delegate to the supervisor in their absence.
• Participate in the training and mentoring of team members on the manufacturing floor.
• Write, revise, and review manufacturing related documents as appropriate.
• Participate in Safety and Continuous Improvement Teams and may serve in a leadership role.
• Initiate and/or coordinate other process improvement projects.
• Drive performance of team members by promoting a positive work environment emphasizing Patient, Trust, Reputation, and Business.

What you bring to Takeda:

• High school diploma or GED. 6+ years of experience or AA or higher with 4+ years related work experience.
• Ability to lead a team.
• Experience exercising proper judgment with regards to Safety, Quality, Compliance, and Production decisions.
• In-depth process knowledge of related manufacturing techniques and specialties.
• Advanced automation experience using DeltaV, Electronic Batch Management, PLC, etc.
• Familiarity with pharmaceutical production equipment including but not limited to centrifuges, filtration systems and CIP/SIP (Clean in Place/Steam in Place).
• Will read and follow detailed written procedures.
• Can apply quantitative analysis to analyze process performance.
• Must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.
• Knowledge of basic chemical and biological safety procedures.
• Must have good computer skills including knowledge of Microsoft Office applications. Experience with applications such as LIMS and JD Edwards preferred.

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:

• Must be able to lift, push, pull and carry up to 50 lbs.
• Must be able to stand for extended periods of time throughout the duration of an 8- or 12-hour shift.
• Must be able to climb ladders and stairs while wearing special gowning.
• May require bending, twisting, reaching, and/or squatting motions to perform certain tasks.
• Must have a robust understanding of cGMPs and other regulatory guidelines applicable to the medical/pharmaceutical industry.
• In general, the position requires a combination of sedentary work and walking around observing conditions in the facility
• Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
• No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
• Will work around chemicals such as alcohol, acids, buffers and filter aid that may require respiratory protection. Facial hair must be removed if required to wear respirator.
• Will work in a cold, wet environment.
• Must be able to work multiple shifts, including weekends.
• May work in a confined area.
• Some Clean Room and cool/hot storage conditions.

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-MA1

Takeda Compensation and Benefits Summary

For Location:

USA - CA - Los Angeles

U.S. Hourly Wage Range:

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.

Locations

USA - CA - Los Angeles

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

No