Microbiological/Environmental Monitoring Manager and Investigator - Boston, MA, United States - Takeda Pharmaceutical

Description

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Job Title:
Microbiological/Environmental Monitoring Manager and Investigator

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.

Influence the organizational control of

Quality Systems:

Manage investigations, deviations, change controls, and improvement initiatives related to microbiological issues and contamination investigation regarding impact to lot release for commercial manufacturing.

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 .

Liaise and collaborate with key stakeholders (PIER, Manufacturing Sciences, Quality Sciences, Analytical Development and Center functions) as applicable.

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
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
Understand Takeda's business, objectives and operations and how own activities fit within the company strategy

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.

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.

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.

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.

#The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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.

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.

Full time