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.
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
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
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).
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
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.
Takeda Pharmaceutical Company Ltd