20 days old

Associate Director, Vaccine Analytical Development (Biophysical)

Takeda Vaccines, Inc.
Cambridge, MA 02139
  • Job Code
    R0013855

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Job Description

OBJECTIVES:

The Associate Director position within Vaccine Analytical Development (AD) will be responsible for:

  • Independently designing and developing biophysical methods for use in lot release testing and/or characterization of vaccine products at all stages of development.
  • Participate in the design and implementation of methods, method qualifications and transfers to 3rd party vendors, and supervising creation and review of necessary SOPs and development reports.
  • Present scientific data and represent the AD group on cross-functional teams.
  • Identify new analytical technologies and leading their assessment and potential implementation in AD.

ACCOUNTABILITIES:

  • Development and qualification of analytical methods for high-level characterization of vaccine-related components.
  • Utilize internal and external networks to maintain and enhance current knowledge of emerging technologies in bioanalytics to support improvements for existing analytical strategies.
  • Proficient and knowledgeable in chromatographic (SEC, IEC, RPLC), electrophoretic (CE, icIEF, SDS-PAGE), particle analysis (NTA, FlowCam) and mass spectrometric methods (peptide maps, intact mass determination) for analysis of proteins, and the development and qualification of such methods.
  • Writing and reviewing technical documents and regulatory submissions.
  • Manage and develop a small group of scientists to achieve AD objectives

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • PhD and a minimum of 6 years experience or MS and a minimum of 8 years experience in vaccine or biologics assay development.
  • Strong scientific background with extensive hands-on experience in a broad array of biochemical/biophysical techniques is required.
  • Extensive experience with experimental design, data analysis, organization and presentation of complex scientific data.
  • Demonstrated ability to propose strategy and manage development, qualification, documentation, and transfer of assays.
  • Prior experience managing direct reports in protein analytical method development and/or testing is a plus.
  • Prior experience working in a biopharmaceutical product development environment and familiarity with GMPs and FDA/ICH guidelines is preferred.
  • The candidate should be a self-starter and team player who can balance the needs of an entrepreneurial environment with the requirements of a GMP testing environment.

PHYSICAL DEMANDS:

  • Manual dexterity required to operate office equipment (e.g. computers, phones, etc.).
  • Typical office and laboratory bending, stooping and lifting requirements.
  • Lifting and moving supplies and equipment (up to 50 pounds).

TRAVEL REQUIREMENTS:

  • Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
  • Up to 20-25%

Learn more at takedajobs.com.

No Phone Calls or Recruiters Please.

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Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





Posted: 2019-11-01 Expires: 2019-11-30
Sponsored by:
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Sponsored by:
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Associate Director, Vaccine Analytical Development (Biophysical)

Takeda Vaccines, Inc.
Cambridge, MA 02139

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