Microbiological/Environmental Monitoring Manager and Investigator
Multiple LocationsAt Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a part of our team, you’ll do meaningful work that makes an impact on the lives of patients. Learn more about us and explore the opportunities to build a remarkable career.
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Job Description
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.
#GMSGQ #ZR1 #LI-MA1
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 OPSU.S. Base Salary Range:
$108,500.00 - $170,500.00The 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.
Locations
USA - MA - Lexington - BIO OPSBoston, MAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeWorking at Takeda
-
Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team. -
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission. -
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients. -
Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024. -
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family. -
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Patient
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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