Job Description

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Job Description

About the role

This is an onsite leadership role responsible for overseeing the Contamination Control Program (CCP) and driving microbial control strategy initiatives at our Los Angeles manufacturing site. The primary objective is to reduce bioburden and strengthen the site's overall contamination control framework.

The role will lead the development and execution of the site’s contamination control strategy and quality risk management (QRM) efforts, ensuring alignment with both site-level and global goals. Success in this position requires close collaboration with cross-functional partners in manufacturing, quality assurance, engineering, validation, and facilities to implement sustainable improvements and uphold the highest standards of microbial control.

How you will contribute

• Lead and coordinate the Los Angeles site’s Contamination Control Program (CCP), driving strategic initiatives to reduce microbial risk and improve product quality
• Guide cross-functional and cross-site teams through complex challenges, including high-impact bioburden investigations, to mitigate potential supply disruptions
• Analyze data critically to identify opportunities for process robustness and contamination control improvements
• Prepare clear, well-documented investigation reports, trend analyses, and microbial impact assessments
• Define and implement contamination control strategies (CCS) while fostering a culture of continuous improvement in aseptic technique and behavior
• Conduct risk assessments and develop mitigation strategies to proactively address potential sources of contamination
• Serve as a Subject Matter Expert (SME) for contamination control, providing technical support for process improvements, change controls, deviation investigations, and CAPA implementation
• Collaborate with training teams and SMEs to develop and communicate best practices across the Los Angeles manufacturing site
• Lead monthly CCP team meetings and actively participate in Takeda’s global CCP community of practice
• Represent Los Angeles QC Microbiology in global forums and share best practices across the network
• Act as the primary point of contact for inspection readiness related to contamination control, including presenting during regulatory inspections
• Coach and mentor others on microbiology and contamination control topics
• Lead or support investigations related to microbial contamination or excursions
• Support new product transfers by contributing to contamination control aspects of process and equipment design, microbial method validations, and rapid microbial methods
• Conduct microbial risk assessments for new products and processes
• Perform other duties as assigned to support site and global quality objectives

What you bring to Takeda

·A bachelor’s degree, preferably in a scientific, engineering, or other related technical field

·6+ years of relevant experience, ideally in commercial biotechnology or pharmaceutical manufacturing environments

·Proven experience managing projects and developing schedules in a regulated production setting

·Strong knowledge of Lean/Six Sigma methodologies and the DMAIC problem-solving process

·Experience with Rapid Micro Methods (RMM) is preferred

·Green Belt training or certification is a plus

·Proficiency in Microsoft Project, Word, Excel, and PowerPoint

·Demonstrated ability to remain agile, positive, and composed in a fast-paced environment

·Working knowledge of microbial risk assessments such as HACCP and FMEA is desirable

·Solid understanding of cGMPs and their application in biologics manufacturing

·Familiarity with Quality by Design (QbD) and Quality Risk Management (QRM) principles is preferred

About our Los Angeles Facility:

At our Los Angeles manufacturing site, we’re united by a powerful purpose: producing life-changing plasma-derived therapies for individuals living with rare, chronic, and genetic conditions such as immunodeficiencies. With over 70 years of innovation and leadership, our facility is a cornerstone of excellence in the industry.

In 2018, our commitment to innovation and operational excellence was recognized by the International Society for Pharmaceutical Engineering (ISPE), which honored us with two Facility of the Year Awards (FOYA):

• Category Winner for Facility Integration and Overall Winner for our Los Angeles Master Plan (LAMP) project
• Category Winner for Operational Excellence for our Los Angeles QC Lab project

These accolades reflect our dedication to continuous improvement and cutting-edge facility design. Here, you’ll join a team that’s always looking ahead—finding smarter, more efficient ways to make a meaningful impact every day.

For more information, please visit: https://www.takeda.com/what-we-do/manufacturing-sites/los-angeles/

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs and company match of charitable contributions
• Family Planning Support
• Flexible Work Paths
• Tuition reimbursement

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:

• 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.
• Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

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.

This posting excludes Colorado applicants.

Empowering our people to shine:

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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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. Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary 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 base salary 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 and/ or long-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.

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Job Exempt