Job Title: Microbiological/Environmental Monitoring Manager and Investigator
Location: Lexington, MA

About the role:

Primary duties of this position include serving as a lead for various technical aspects of the QC and Mass Bio Ops areas. You will provide both subject matter expertise and technical leadership on activities such as microbiological/environmental monitoring issues, investigations, quality events, data analysis and trending, key program oversight, and collaboration on several teams. You will also help manage departmental and cross-functional teams occasionally.

You will report to The Associate Director of QC Support.

How you will contribute:

• Influence the organizational control of Quality Systems: Create/monitor/author deviations, Out of Specification (OOS) and Out of Trend (OOT) and unexpected events. Monitor GMP investigations progress and support process to closure. Escalate conflicts that arise.
• Provide microbiological subject matter expertise and consultation to QC and the Mass Bio Ops organization.
• Establish microbiological standards to enable best practices and ensure cGMP compliance across QC and Mass Bio Ops.
• Lead technical improvement initiatives related to microbiological issues and contamination control.
• Manage investigations, deviations, change controls, and improvement initiatives related to microbiological issues and contamination investigation regarding impact to lot release for commercial manufacturing. Includes being a subject matter expert for and conducting comprehensive investigations to determine potential product impact, identify cause, and implement corrective and preventative actions observing established procedures and timelines.
• Lead management and perform document change requests for risk assessments, policies and method SOPs.
• Work with the Mass Bio Ops contamination control program and community of practice.
• Regulatory inspection preparation, audit support, and remediation across MBO network.
• Support enhancement of Tiered board system, including development and monitoring of metrics intended to drive business process improvements .
• Collaboration with peers to drive the alignment of the QC teams’ activities across the sites.
• Liaise and collaborate with key stakeholders (PIER, Manufacturing Sciences, Quality Sciences, Analytical Development and Center functions) as applicable.

What you bring to Takeda:

• BS Degree in Science or Engineering with 8 years of relevant experience
• Proven record of cross-functional technical leadership, including, motivate, and lead technical rigor
• Knowledge of cGMP and other regulatory requirements related to manufacturing of biologics and monoclonal antibodies.
• Strong technical skills and experience in commercial biopharmaceutical Quality/Manufacturing in the areas of microbiology, environmental monitoring, microbiological testing, cell culture and/or purification, engineering or validation
• Experience leading cross functional teams
• Must possess knowledge of cGMP, commercial operations and root cause analysis tools
• Excellent verbal and written communication skills, including demonstrated ability to effectively present to senior management and regulatory inspectors
• Foster environment of learning and continuous improvement
• Actively seeks ways to improve current systems and processes related to own activities
• Systematically seeks and applies best practices for problem solving and gap identification beyond one’s comfort level. Expands problem solving abilities by assimilating new effective approaches.
• Understand Takeda’s business, objectives and operations and how own activities fit within the company strategy

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.
• Limited travel expected. Travel between sites within Massachusetts is required.

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.

Work policy.

Preference will be given to candidates with a remote location near, and availability to work during the working hours of, the corporate office in Boston, Massachusetts.

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