Posted to MedZilla on 6/22/2017


Takeda Pharmaceuticals

US-MA, Associate Director, Vaccine Formulation - Vaccine Business Unit 1701198-MZ


 
 

Empowering Our People to Shine

Takeda is a global, innovation-driven pharmaceutical leader with 30,000 professionals working together across 70+ countries. We have an unwavering dedication to put patients first for more than 230 years while we live our values of Takeda-ism Integrity, Fairness, Honesty, and Perseverance. We are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people s lives including your own.

OBJECTIVES:
  • Directs, oversees the optimization, , large scale-up of Drug Product.
  • Prepares process comparability reports
  • Supports Takeda site where DP Tech transfer is currently happening. Leads activities to ensure a robust Drug Product manufacturing process to cover DP pipeline
  • Provide professional information, input, and review as needed for USFDA and other non-US regulatory agency submissions.

ACCOUNTABILITIES:

  • Design, test, transfer, and oversees unit operations for manufacture of Final Drug Product (FDP). Operations include, but are not limited to, complex aseptic formulation, solubilization and filter sterilization of hydrophobic compounds and aqueous solutions, continuous mixing, and fill finish into vials and/or prefilled syringes.
  • Manage off-site CMO s for various aspects of FDP manufacturing including authoring and reviewing of Batch Records/Master Production Records specific to unit operations, reagent acquisition, raw material specifications, transfer of in-process analytical testing methods, and person-in-plant for GMP activities.
  • Develop and test formulations to improve product stability, facilitate manufacturing processes, prolong shelf life, and set product specifications.
  • Design and implement protocols for technical evaluation of product-related devices; e.g., bulk Drug Substance and FDP storage containers/contact surfaces and Drug Product delivery devices.
  • Design and implement protocols for product stability studies, both long-term and accelerated.
  • Coordinate product and process characterization studies off-site with various CMOs/CTOs and prepare reports for regulatory submissions.
  • Author and review CMC documentation, including technical and quality sections, for submission to regulatory agencies; e.g., IND, CTD.
  • Participate and, as applicable, make presentations in both internal and external technical reviews, including regulatory discussions.
  • Other duties as needed.
Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • A PhD in Chemistry, Pharmaceutics, or Life sciences, or equivalent education.
  • Minimum of 10 years experience in the pharmaceuticals, biologics, manufacturing
  • At least 5 years experience in a GMP manufacturing environment.
  • Thorough understanding of all aspects of the R&D process.
  • Knowledge of GMPs and CMC regulatory requirements concerning drug development.
  • Maintain in-depth knowledge of state-of-the-art principles and theories, applying such knowledge that supports the company s goals.
  • Possess excellent verbal and written communication skills and interpersonal skills, together with highly developed motivational and organizational skills.
  • Skillfully exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results.
  • Demonstrate technical proficiency, scientific creativity, collaboration with others, and independent thought in suggesting experimental design and research strategy.
  • Think critically and creatively and effectively work independently and determine appropriate resources for resolution of problems.
  • Effectively recognize anomalous and inconsistent results and interpret experimental outcomes.
  • Effectively represent the pharmaceutical development function both internally and externally.
  • Skilled in use of office software packages and scientific software applications.
  • Exhibit and promote Takeda Core Competencies

TRAVEL REQUIREMENTS:
  • Willingness to travel to sites for DP tech transfer work. International travel may be required.
  • Requires approximately 30% 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

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.

*LI-KB1-USA


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.