Posted to MedZilla HealthCare on 10/20/2018


Takeda Pharmaceuticals

US-MA, Manager II, Technical Operations, Drug Product R0004525-MZ


 
 

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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 Manager II, Technical Operations in our Boston, MA office.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As Manager II, Technical Operations working on the Pharmaceutical Operations team, you will be empowered and a typical day will include:

The Manager II, Technical Operations will be responsible for providing technical support and leadership within Technical Operations relating to the global external manufacturing of commercial Oncology and Biologics Drug Product.
The individual will be responsible to manage and lead technical issue resolution relating to oncology/biologics product(s) or key major technical projects within Technical Operation, with minimal oversight. The individual will be directly responsible for commercial manufacturing of drug dosage forms, drug product manufacturing process design, optimization, scale-up, technology transfer and validation.

Additionally, the candidate will provide technical leadership in support of other Takeda products that are managed by other colleagues.

ACCOUNTABILITIES:

  • Provide day-to-day leadership in Technical Operations in managing technical activities for commercial drug product manufacturing i.e., trouble shooting, process changes and improvements, new manufacturing technology implementation etc.
  • Support CMO manufacturing activities and be a technical lead between Technical Operations and third-party drug product manufacturers.
  • Provide guidance and leadership to support Global Oncology and Biologics Operations/Quality organizations (Supply Ops, QA, QC) in compiling and analyzing production data, such as IPC, release, and manufacturing process information.
  • Lead and provide clear direction in the presentation of the above data summary to improve manufacturing efficiency and be responsible for the presentation of such data to other internal and external groups.
  • Author pertinent SOP s and manufacturing process instructions.
  • Technical lead in the preparation of Change Controls, investigations, and CAPAs.
  • Provide authorship for Agency submissions supporting product approval and inquiries.

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

The candidate should have a BS in chemistry, chemical engineering or related discipline and 7 yrs of experience working in commercial pharmaceutical discipline. The candidate should have a good working knowledge of aseptic manufacturing operations, and/or drug product manufacturing (oral solid dose and parenteral) with experience with lyophilization preferred. The candidate also needs to have an excellent knowledge of CMC regulations, cGMP, sterility assurance techniques and FDA guidance s. The candidate should be an expert in Excel as well as other Microsoft Office suite software. The candidate should have demonstrated written and oral communication skills and ability to work in a cross functional team environment.

TRAVEL REQUIREMENTS:

  • Ability to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
  • Position requires up to 30% 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.

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Please visit our website at takedajobs.com

 
 


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