21 days old

Sr. Scientist - DMPK

Millennium Pharma, Inc.
Boston, MA 02109
  • Job Code
    R0013966

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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 our bioanalytical group within the Global DMPK department at our Cambridge, MA site. You will be a vital contributor to our inspiring, bold mission. Within the Global DMPK department, you will be empowered to focus on preclinical stage bioanalytical support of PK/CK, Bio-distribution, PD, immunogenicity, and biomarker studies for discovery and development of our biologics, cell, and gene therapy pipelines.

We are seeking individuals with broad technical expertise and relavent industry experience to support diverse therapeutics development programs. The ideal candidates are expected to hold themselves to a high bar in terms of results driven, self-motivation, resiliency, and applying learning to stretch and grow as a professional to help the department with the key goal of progressing novel biologics, cell and gene therapies from discovery to the clinic and beyond.

Core Responsibilities

  • Adopt/develop innovative technologies and platforms to address bioanalytical challenges and needs to support the discovery and development of innovative therapeutic biologics.
  • Independently design, develop, troubleshoot, and qualify PK/CK, PD, ADA, and biomarker assays using ELISA, MSD, Gyros, Simoa, qPCR, FCM, or other immunoassay platforms to support nonclinical studies.
  • Use internal and external (CRO) resources to design, development, troubleshooting, transferring, and monitoring of qualification/validation/reporting of PK/CK, PD, immunogenicity, and biomarker assays to timely and quality support of drug discovery and nonclinical development activities.
  • Prepare/scientific review of analytical data and methods, protocols, and reports generated by internal and external laboratories.
  • Maintain abreast with the latest bioanalytical methods and technologies, current GLP regulation, regulatory guidance, and industrys best practices.
  • Scientifically manage and interact/collaborate with CROs, as necessary to support projects.
  • Participate and present results in departmental and cross-functional project team meetings.
  • Serve as Bioanalytical representative to interact with the DMPK and project reps on discovery/development programs.

Education and Experience Requirements

  • PhD in molecular biology, biochemistry, genetics, cell biology, or other related field with a minimum of 5 years or MS with a minimum of 8 years of relevant industry research experience and a strong publication record.
  • In-depth knowledge and hands-on experience in PK/CK, PD, immunogenicity, and biomarker assays development and troubleshooting using qPCR, RT-PCR, ddPCR, ELISA, MSD, Gyros, Simoa, FCM, or other novel platforms for different drug modalities.
  • Extensive Hands-on experience in primer/probe design for qPCR and ddPCR, Taqman assay development, optimization, trouble shooting, and results analysis is required.
  • Experience in PCR method qualification/validation, cell-based assay development such as NAb assay, or flow cytometry are highly desirable.
  • Solid experience in analytical method development and qualification and validation of relevant methods in a GLP compliant environment is highly desirable.
  • Strong experience and track record with bioanalytical support of nucleic acid drug (such as siRNA, ASO, mRNA, or gene therapy) is highly desirable.
  • A strong self-starter, independent strategic thinker, with a strong attention to details and excellent problem solving and complexity reduction skills.
  • Good understanding of regulatory expectations and evolutions on bioanalytical and immunogenicity assay development/validation and sample analysis to support non-clinical development of new modality therapies.
  • Strong scientific background and familiarity with early stage drug development.
  • Excellent communication, interpersonal, and presentation skills, capable of conveying technical information in a clear and thorough manner.
  • The ability to work in a fast-paced and dynamic team environment, managing multiple projects with a high emphasis on quality and timelines, overcoming challenges, developing, and implementing effective strategies are essential.

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

    Discover more at takedajobs.com

    No Phone Calls or Recruiters Please.

    #LI-JT1

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





Posted: 2019-10-31 Expires: 2019-11-29
Sponsored by:
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Sponsored by:
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Sr. Scientist - DMPK

Millennium Pharma, Inc.
Boston, MA 02109

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