Head of Contamination Control and Microbial Assurance

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Job Description

About the role:

As the Head of Contamination Control & Microbial Assurance at the Massachusetts Biologics Operations (MBO) facility, you will be responsible for the development, oversight, and management of the Contamination Control Strategy (CCS) program. This role requires strong expertise in microbiology, manufacturing, and facility controls to manage and mitigate microbial risks in biologics manufacturing. This role ensures microbial quality, regulatory compliance, and operational excellence through robust contamination control governance, risk management, and cross-functional collaboration. As a member of the Site Quality Leadership team (QLT) this role is pivotal in fostering innovation and efficiency in contamination management while supporting the site's commitment to product quality, environmental sustainability, and operational growth. You will report to the Site Quality Head, Massachusetts Biologics.

How you will contribute:

• Develop and lead site-wide contamination control and microbial assurance programs to maintain low bioburden manufacturing standards
• Chair the CCS governance for MBO, ensuring strategic alignment and oversight of effective contamination control measures across the facilities
• Oversee environmental monitoring, bioburden testing, and microbial analytics to ensure compliance with microbial quality requirements
• Lead investigations into microbial contamination events, root cause analysis, and implementation of corrective and preventive actions (CAPAs)
• Lead a matrix team that drives accountability within the CCS governance structure
• Collaborate with manufacturing, engineering, manufacturing sciences and supply chain teams to drive a culture of contamination prevention and continuous improvement
• Ensure effective implementation and governance of contamination risk mitigation measures, including but not limited to: cleanroom design, personnel practices, and equipment qualification
• Establish contamination control metrics and key performance indicators (KPIs) to track and report progress against site goals

Minimum Requirements/Qualifications:

• Bachelor's degree in Microbiology, Biochemistry, Pharmaceutical Sciences, Biological Engineering or related field. Strong preference to microbiology
• 5+ years of experience in contamination control, cleanroom operations, and/or aseptic processing operations within the biologics or pharmaceutical industry
• Comprehensive knowledge of global GMP regulatory requirements for biologics manufacturing
• Demonstrated ability to solve problems, drive improvement, and develop plans and advance to completion on time and in full
• Diverse technical understanding and ability to apply skills/knowledge to new technology
• Knowledge of Lean/Six Sigma and the DMAIC problem solving process is preferred

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 position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

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 - MA - Lexington - BIO OPS

U.S. Base Salary Range:

$149,100.00 - $234,300.00

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-termincentives. 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.

LocationsUSA - MA - Lexington - BIO OPS

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.