Posted to MedZilla on 10/17/2017


Takeda Pharmaceuticals

US-MA, CMO Operations Manager 1702506-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 CMO Operations Manager in our Cambridge Massachusetts office. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission.
As a CMO Operations Manager working on the Pharmaceutical Operations team, you will be empowered to manage the global contract manufacturing relationships for commercial drug product-lyophilized parenterals and capsules and the management of oncology therapies distributed globally while identifying continuous improvement and process improvement opportunities, and a typical day will include:

POSITION OBJECTIVES:

  • Work together with Quality Assurance, Quality Assurance/Control, Regulatory Affairs, and Technical Operations to ensure product quality and supply demand is consistently met for Takeda s Commercial Products.
  • Lead day to day management of routine production of Drug Product and Finish goods packaging sites.
  • Serve as the primary CMO contact for operational and businessrelationship activities.

POSITION ACCOUNTABILITIES:

  • Lead a core team comprised of QA, QC, Regulatory Affairs, Technical Operations, and Logistics, and Supply Operations Systems personnel to effectively manage CMOs.
  • Responsible for initiation and timely resolution of deviations and change controls associated with routine manufacture of drug product and finished goods. Triages out to Technical Operations for troubleshooting, and management of in depth process investigations, as appropriate.
  • Author, reviews, and/or approves pertinent SOP s and manufacturing process instructions, pertinent CMC sections for regulatory submissions, and participate in CMC teams for key therapeutics distributed globally.

EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS:

  • Bachelor s degree required, ideally in; chemistry, biology, or closely related disciplines
  • 5+ yrs of experience working in manufacturing, supply chain, or pharmaceutical development.
  • Working knowledge of manufacturing operations, biologics drug substance manufacturing, drug product manufacturing (oral solid dose and/or parenterals,) pharmaceutical packaging, CMC regulations, cGMP, and sterility assurance techniques.

TRAVEL REQUIREMENTS:
  • Position requires up to 25% domestic and international 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


Please visit our website at takedajobs.com

 
 


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