The Translational and Biomarker Research assay group at Takeda is a state of art laboratory responsible for using various technological approaches to support clinical development. Biomarker assays are used to expand our knowledge of new development candidates for treatment of cancer, CNS and GI related disorders and predicting which patients are likely to respond to new therapies. To expand our lab capabilities we are looking for an associate with extensive laboratory experience to develop, validate and transfer biomarker assays to clinical and non-clinical outsource labs as appropriate. This person will work with internal groups and outside contract organizations to ensure timely development and implementation of clinical biomarker assays using various technology platforms. Additional opportunities include creation of contracts with outsourcing labs, participating in vendor audits, oversight of shipment of clinical trial samples to the outsourcing labs and QC of the resulting biomarker assay data.
- Works with the
Translational and Biomarker Lead Scientist,
Translational and Biomarker Research Logistics group, Clinical Operations
and Clinical Outsourcing to ensure biomarker assay needs for
clinical development strategy are delivered within the required study
strategic, technical and scientific leadership for the execution of these
assays for assigned program(s).
with the Discovery units to ensure timely transfer of biomarker assays to the
Translational and Biomarker Research assay group for method development
develops biomarker assays and designs assay validation studies using various
technology approaches according to the fit-for-purpose principle. Works with
Procurement to ensure timely execution of validation and clinical contracts
with outsourcing labs.
outsourcing labs responsible for validating biomarker assays and monitors the
scientify quality of the assays during study conduct.
to present biomarker data in clear and succinct fashion at project team and
include approxitmately 30% lab work and 70% outsourcing and clinical trial
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Experience: BS/MS with 3-5+ years of pharmaceutical or CRO experience
- Relevant industry experience is a must
- Demonstrated expertise in one of two technical areas including, but not limited to,
- Next-generation DNA and RNA sequencing, IHC, and CTCs.
- Flow cytometry, mass cytometry and immunoassays
- Extensive hands on experience with
- For next-generation sequencing and IHC: DNA and RNA extraction and QC of whole blood, PAXgene blood, fresh or frozen tissue, cell lines, formalin fixed paraffin embedded (FFPE) tissue, fresh-frozen tissues and Buccal swabs
- For flow cytometry assays: Independently operate flow cytometers such as BD FACSCANTO II. Understand compensation and the complexities of polychromatic flow cytometry from 8+ colors. Independently analyze data, including flow cytometry data, with interpretation of results and proposals for next steps. Hands-on experience with BD LSR Fortessa instruments is highly desirable.
- For immunoassays: Independently operate mesoscale discovery systems (MSD), Luminex instrument, microplate washers and microplate readers. Able to develop different types of ELISA assays, including sandwich and competitive ELISAs. Independently analyze data, including immunoassay data, with interpretation of results and proposals for next steps.
- Ability to independently maintain various cell lines
- Biology background, experience with clinical biomarker assay development
- Experience with NGS technologies and data QC is highly desirable
- Experience with outsourcing is highly desirable
- Strong organizational skills, attention to detail, ability to work independently
- Excellent written and oral communication skills
- Occasional National and International travel.
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