Posted to MedZilla on 11/20/2017


Takeda Pharmaceuticals

US-MA, Manager II, Quality Control Commercial Quality Operations 1702154-MZ


 
 

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 Manager II, Quality Control Commercial Quality Operations in our Cambridge, MA office.


Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager II, Quality Control Commercial Quality Operations working on the Quality Control team, you will be empowered to bring knowledge of Biologics and lead a team within the Quality Control organization. A typical day will include:

POSITION OBJECTIVES:
  • Manage oversight of analytical test methods at contract manufacturing organizations and contract testing organizations for Biologics products.
  • Lead method troubleshooting, improvements and implementation activities within and outside Takeda.
  • Lead Method Validations and Transfer activities to CTOs.
  • Conduct and resolve analytical investigations and deviations.
  • Lead training and on-boarding activities for new employees.
  • Author and review analytical sections of regulatory filings and responses to Health Authorities.
POSITION ACCOUNTABILITIES:
  • Liaise with Analytical Development groups to bring knowledge to QC.
  • Ensure validation meets ICH guidelines and methods are QC user friendly.
  • Review analytical sections and response to questions for initial regulatory filing.
  • Provide scientific support as needed to members of QC.
  • Initiate Change Controls to change vendor test methods.
  • Provide QC representation for CMC and regulatory team meetings.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • Bachelors or a Masters degree in Analytical Sciences or Life Sciences.
  • Extensive experience in analytical method development, qualification and validation of assays of biologics products. Experience with Bioassays and impurity assays such as FACS Binding, Adhesion, HCP and Protein A is a plus.
  • 10 + years experience in pharmaceutical or bio-pharma preferred with at least 2 years of supervisory experience.
  • Computer skills preferably include Word, Excel, Trackwise or electronic document repositories, experience with SAS JMP a plus.
TRAVEL REQUIREMENTS:
  • Up to 10% 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.

Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx

No Phone Calls or Recruiters Please.


Schedule
Full-time


Please visit our website at takedajobs.com

 
 


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  considered, please do so. Applications for all positions are subject to each employer's specific requirements.