Current Statistics
1,431,407 Total Jobs 276,467 Jobs Today 17,279 Cities 222,692 Job Seekers 146,724 Resumes |
|
|
|
|
|
|
Microbiological/Environmental Monitoring Manager and Investigator - Boston Massachusetts
Company: Takeda Pharmaceutical Location: Boston, Massachusetts
Posted On: 04/26/2024
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionJob Title: Microbiological/Environmental Monitoring Manager and InvestigatorLocation: Lexington, MAAbout 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 strategyImportant Considerations:
|
|
|
|
|
|
|