Microbiologist QC Manager Cell Therapies

Takeda Pharmaceutical Company Ltd Boston , MA 02298

Posted 3 months ago

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Job Description

Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Microbiologist QC Manager Cell Therapies in our Cambridge office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Microbiologist QC Manager Cell Therapies working on the Investigational Medicinal Product Quality Advanced Therapies team, you will be empowered to drive and be the Lead in all microbiological matters regarding our clinical manufacturing of new investigational cell therapies products.

OBJECTIVES:

  • The Microbiologist QC Manager Cell Therapies is responsible for the Contamination Control Program of the Cell Therapies Manufacturing Facility

  • Subject matter expert in microbiology of cleanrooms

  • Subject matter expert in aseptic processing of sterile drugs

  • Responsible for overseeing all microbiological related activities and testing within the Cell Therapies Manufacturing Facility

  • Leading continuous improvement of internal GMP Microbiology QC laboratory

ACCOUNTABILITIES:

  • Responsible for authoring and overseeing implementation of the contamination control program of the cell therapies manufacturing facility

  • Subject matter expert of cleanroom design, airflow and pressurization control, cleaning and disinfectant, cleanroom gowning, cleanroom behavior, aseptic techniques, in coming raw materials control, and utilities monitoring and control.

  • Responsible for authoring and overseeing implementations of environmental monitoring performance qualifications and routine environmental monitoring programs

  • Responsible for authoring microbiological related plans, protocols, reports, SOPs and other relevant GMP documents

  • Subject matter expert and lead in all microbiological related Out of Specification (OOS) or Out of Trend (OOT) analytical results, deviations, investigations, corrective or preventive actions

  • Recommend product disposition and corrective action measures when deviations occur related to microbiology specifications

  • Subject matter expert and contributor to aseptic process simulations/media fills

  • Evaluate container closure systems and their suitability

  • Oversight of microbiology related routine monitoring, utility monitoring, raw material and product testing activities internal as well as performed by contract testing laboratories

  • Responsible and oversight of microbiological method verifications and qualifications (sterility, mycoplasma and endotoxin)

  • Ensure that all applicable microbiological related US, EMA and Japanese GMP requirements are being met

  • Responsible for trending microbiological related data and reporting microbiological issues to the Quality Council

  • Work closely and collaboratively with cross-functional team as the microbiology lead

  • Local site contact person for Global Microbiology, participate in global microbiology meetings and provide local information as requested and ensure alignment of local microbiological activities with global standards and SOPs.

  • Additional duties as assigned

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Master's Degree or higher in Microbiology

  • Minimum of 7 years' of demonstrated work experience in the pharmaceutical industry

  • Minimum of 5 years' experience in QC Microbiology with increasing responsibility

  • Thorough knowledge of US and European GMPs and Pharmacopeia

  • Expert in contamination control of GMP cleanroom facilities

  • Expert in aseptic processing of sterile drug substances and drug products

  • Subject matter expert with practical experience of environmental monitoring testing and product testing (sterility, mycoplasma, endotoxin)

  • Excellent technical writing and computer skills

  • Excellent organizational, communication, and interpersonal skills

  • Ability to adapt to changing priorities

PHYSICAL DEMANDS:

  • In general, the position requires a combination of mostly sedentary work but also standing for extended periods of time in cleanrooms as needed.

  • This role supports pharmaceutical production operations therefore the work environment may include exposure to production and cell processing facilities, packaging, component printing and analytical laboratories (this list is not exhaustive).

TRAVEL REQUIREMENTS:

  • Requires no travel.

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan

  • Tuition reimbursement

  • Company match of charitable contributions

  • 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

Empowering Our People to Shine

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

#LI-LR1

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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Microbiologist QC Manager Cell Therapies

Takeda Pharmaceutical Company Ltd