Translational Medicine tissue-based assay expert
We Aspire to Cure Cancer! Millennium is a leading biopharmaceutical company focused on oncology that combines the agility, ideals and camaraderie of a start-up with the resources of Japan's largest pharmaceutical company. The result is a creative, entrepreneurial environment where quality science and making a difference in patients' lives are the priorities. Here, employees who share a drive and commitment to innovation for the benefit of oncology patients find their ideas, experience and contributions are valued and rewarded.
Millennium offers great benefits, a friendly and respectful atmosphere, and a culture that promotes flexibility between work and life and encourages employees to give back to their community.
Position Summary: Oncology experienced required for this role. The Global Translational Medicine Biomarker Assay development and implementation group at Takeda is a state of art clinical 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 various diseases.
To expand our lab capabilities we are looking for a manager with extensive lab experience to develop, optimize biomarker assays and technology transfer to clinical testing labs. 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 responsibilities include external lab management, clinical biomarker data review and various clinical trial study support activities.
Duties and Responsibilities:
* Collaborate to transfer tissue based biomarker assays from Discovery groups across Takeda organization , develop, optimize and validate IHC, and FISH based biomarker assays according to “fit-for-purpose” principle
* Interact with contract organizations to outsource the biomarker assays for clinical trials
* Collaborate with Clinical Outsourcing and Clinical Operations to ensure timely technology transfer, assay validation and data collection in clinic
* Review emerging clinical biomarker data for quality
* Represent the department as a subject matter expert during external lab audits
* Present biomarker data at projects team meetings
* Responsibilities include 20-30% of lab work and 60-70% of outsourcing and clinical trial support activities.
Qualifications: Experience: MS with 5+ years of industry experience
* Relevant industry experience in the Oncology field is a must
* Extensive hands on experience with immunohistochemistry, FISH, and IF, using pre-clinical and clinical tumors specimens
* Experience with automated IHC platforms including image analysis methods is highly desirable
* Biology background, experience with clinical biomarker assay development
* Experience with technology transfer to the external labs is highly desirable
* Strong project management skills, attention to detail, ability to work independently
* Excellent written and oral communication skills.
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