Associate Director, Quality Control Microbiology Aseptic


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Job Description

Job Title: Microbiology/Aseptic Related BPO
Location: Massachusetts, Boston

About the role:

  • Reporting to Director Quality Control, you will manage strategic global (multi-site, multi-product) microbiology/aseptic programs and improvement activities
  • Lead contamination investigations on-site or remote
  • Identify, drives and align implementation of new technologies (Rapid Microbiological Methods - RMM)
  • Lead network-wide microbiology/aseptic/RMM related Communities of Practice, drives knowledge management and represents Takeda in microbiology related forums, seminars, platforms, conferences, and publications
  • Lead network-wide Contamination Control Program
  • Lead Contamination Investigations (Rapid Response) on-site or remote

How you'll make an impact:

  • Support sites regarding microbiology/aseptic related challenges and questions
  • Organize and facilitate subject specific Global Communities of Practice calls/meetings
  • Overseeing knowledge management, such as collecting and sharing Best Practices and Lessons learnt throughout the network
  • Ensure alignment regarding compendial requirements and guidance by setting and maintaining global procedures on environmental monitoring and critical utilities, cleanroom management and design, microbiological methods (including validations), sterilization and aseptic processing controls.
  • Manage Audit Support on-site and remote and for reflecting any lessons learned in the course of audits into global procedures (as applicable)
  • Assess critical CMO/CTL deviations
  • Provide micro/aseptic related submission support

What you bring to Takeda:

  • Education / experience
  • At least 5 years of experience in a GMP-environment in the pharmaceutical industry is required
  • 3+ years in a microbiology laboratory or comparable, such as in a sterility assurance function are typically required
  • Experience with investigational trouble shooting
  • Experience managing global communities
  • Leadership Behaviors
  • Keep current with literature and latest technologies
  • You conduct work in compliance with cGMPs, safety and regulatory requirements
  • Experience working with strategic programs

What Takeda can offer you:

  • Comprehensive Healthcare: Medical, Dental, and Vision
  • Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous paid time off for vacation, sick leave, and volunteering
  • Community Outreach Programs and company match of charitable contributions
  • Family Planning Support
  • Professional development and training opportunities
  • Tuition reimbursement

Important Considerations

At Takeda, our patients rely on us to create quality products and we aim to create a safe environment for our team members. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product or putting anyone at the site in harm's way. 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.

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.

Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.

This posting excludes Colorado applicants.

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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

Boston, MA

AUT - Vienna - Kärntner Ring

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


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