16 days old

Quality Control Manager - Microbiology

Shire Human Genetic Therapies, Inc.
Lexington, MA 02421
  • Job Code
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Job Description

Quality Control Manager - Microbiology

Lexington, MA

About the role:

Join Takeda as a Quality Control Manager - Microbiology where you will manage the daily oversight and near term strategy goals for the QC Microbiology lab operations while supporting method transfer, validation and method lifecycle activities. You will also guide accountability to achieve targets for commercial and clinical method programs and engage with peers to improve activities. As part of the Quality Control team, you will report to the Associate Director and work with great team members within the facility.

How you will contribute:

  • You will ensure that new method introduction is performed with customer focus that includes consideration for reliability, sustainability, data integrity and general GMP compliance
  • You will oversee supervisor level staff and require direct management of individuals, including goal setting, performance feedback, skills development and mentoring
  • You will promote compliance with cGMP's and SOP's and represent the function in the inspection / audit process while participating in operational excellence projects and promote continuous improvement in the department
  • You will work with techniques such as bioburden, endotoxin testing, growth promotion, biological indicators, conductivity, microbial identification and plate reading
  • You will create processes to be more efficient

What you bring to Takeda:
  • Requires a Bachelor's degree and 10 plus years of relevant QC experience (Microbiology or science related degree preferred)
  • Relevant management experience
  • Strong business awareness (Operations, productivity, continuous improvement)
  • Expertise in microbiological requirements related cGMP pharmaceutical manufacturing and laboratory management
  • Experience with MS Office, LIMS, SAP, Trackise, EDMS, compliance and strong science understanding
  • On few occasions may need to assist at nearby locations, Alewife, North Reading and Cambridge

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 time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs and company match of charitable contributions
  • Family Planning Support
  • Flexible Work Paths
  • Tuition reimbursement

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.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.




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.


USA - MA - Lexington - BIO OPS

Worker Type


Worker Sub-Type


Time Type

Full time

Posted: 2021-11-21 Expires: 2021-12-20
Sponsored by:
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Quality Control Manager - Microbiology

Shire Human Genetic Therapies, Inc.
Lexington, MA 02421

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