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Job Description

This role is an onsite role, responsible for leadership, and implementation of the Los Angeles site Contamination Control Program (CCP) and microbial control strategy initiatives, to reduce bioburden at the site. It will lead the site contamination control strategy and quality risk management (QRM) initiatives designed to develop a microbial control strategy at the site. You will work with partners in manufacturing, quality assurance, engineering, validation, and facilities to manage global contamination control goals and improvement initiatives.

Responsibilities

• Lead and coordinate the site Contamination Control Program.

• Lead cross-site and teams through complex challenges, including high impact bioburden investigations to mitigate supply impact to patients.

• Critically analyze data to recommend opportunities for robustness improvements.

• Compile well written investigation reports, trend reports and microbial impact assessments.

• Lead the definition and implementation of the appropriate contamination control strategies (CCS) and promote the continuous improvement in aseptic technique culture/behavior.

• Conduct risk assessments and develop mitigation strategies to minimize the risk of contamination, identifying potential sources of contamination and developing strategies to mitigate the risk.

• Provide technical support and Subject Matter Expert input for manufacturing-related process improvements, change control, deviation investigation, and CAPA implementation.

• Partner with training team and relevant SMEs to communicate best practices across the Los Angeles Manufacturing site.

• Lead CCP team monthly meetings at the LA site and participate in the Takeda global CCP community of practice.

• Represent Los Angeles QC Microbiology in Global forums.

• Share best practices throughout the network and cascade to functional site teams and leadership.

• You will also support new product transfers coming to the site related to contamination control aspects of manufacturing process and equipment design, microbial method validations and rapid microbial methods.

Education and/or experience

• Typically requires bachelor's degree preferably in science, engineering or other related technical field

• 6+ years of relevant experience in commercial biotechnology or pharmaceutical production managing projects and schedule development is required.

• Lean/Six Sigma and the DMAIC process.

• Experience in Rapid Micro Methods (RMM).

• Green belt training/certification.

Physical Demands

• Must be able to lift, push, pull and carry up to 25 lbs.

• In general, you will have a combination of sedentary work and walking around observing conditions in the facility.

Working Environment

• Will work in controlled environments requiring special gowning. Will 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 in a cold and wet environment.

• May work in a confined area.

• Some Clean Room and cool/hot storage conditions.

• Will visit manufacturing areas for assessments.

• May require availability outside regular business hours.

• Work more than 8 hours a day or 40 hours a workweek.

• Will work in construction area

• Will work 100% 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.

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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.

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