Posted to MedZilla on 9/20/2017


Takeda Pharmaceuticals

US-MA, Associate Scientific Fellow / Senior Scientist, ADL - Structural Characterization 1600811-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 Associate Scientific Fellow / Senior Scientist, ADL - Structural Characterization in ourCambridgeoffice.


POSITION SUMMARY:

In the Analytical Development Laboratories (ADL) of Takeda Pharmaceuticals, Inc. Company in Cambridge, MA where all of the test methods for drug substances and drug products are developed and validated in support of clinical development. ADL scientists work very closely with partner groups such as process chemistry, formulations, discovery, drug safety, regulatory and quality to advance drug candidates from discovery through regulatory submission. ADL scientists also provide strong technical support to commercial product in the market and work in a GLP/GMP compliant environment.


ACCOUNTABILITIES:

The main focus of this role is to contribute to the structural elucidation of new compounds, impurities and degradants providing rapid and efficient small molecule compound structural characterization by mass spectrometry and NMR analyses in support of drug development activities from discovery, through development, to commercialization. Responsibilities will also include: coordinate and manage internal and external resources. Conduct experiments to determine degradation pathways. Conduct method development, validation, transfer and stability testing for drug substances and drug products using modern analytical techniques such as HPLC and GC. Participate in CMC teams and cross-functional teams to plan analytical and CMC strategy for product development. Review and determine the acceptance of analytical work in terms of accuracy and consistency in compliance with FDA, ICH guidelines and internal SOPs. Prepare and review relevant SOPs, protocols, validation, stability reports, regulatory filings and other technical reports to support drug candidate development and regulatory submissions.

QUALIFICATIONS:

  • Preferred Qualifications: Qualified candidates should possess a PhD with 3+ years. Work experience in an analytical development laboratory with strong organic chemistry knowledge. Technical capabilities include, but not limited to, advanced knowledge/experience of HPLC, MS and 1D/2D NMR. GC and GCMS knowledge is a plus. Should have a track record of external scientific contributions (manuscripts, presentations at conferences, etc.). Non-technical capabilities include, but not limited to, project management skills, effective interface with drug substance and drug product development groups, discovery chemists, strong written and oral communication skills, resource management skills and an influential team player in a cross-functional and global environment.
  • Basic Qualifications: PhD in analytical chemistry or closely related field with 3+ years experience in a pharmaceutical, analytical chemistry lab performing structural characterization. Knowledge of cGMPs.


TRAVEL REQUIREMENTS:

  • 25% or less

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
Regular

Please visit our website at takedajobs.com

 
 


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