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Associate Director

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Associate Director, Advanced Analytics, Cell Therapy Company: Takeda Pharmaceuticals International GmbH

Location: Cambridge

Posted on: September 14, 2020

Job Description:

The health and safety of our employees and candidates is veryimportant to us. Due to the current situation related to theCoronavirus (COVID-19), we’re leveraging our digital capabilitiesto ensure we can continue to recruit top talent at Takeda. As yourapplication progresses, you may be asked to use one of our digitaltools to help you through your recruitment journey. If so, one ofour colleagues will explain how these tools will be used during therecruitment process. Thank you.

*Please be aware of an Identity Theft Scheme targetingindividuals seeking jobs with Takeda and other employers. See belowor here for more info.

Associate Director, Advanced Analytics, Cell Therapy Takedafosters a collaborative and stimulating work environment filledwith opportunity and the chance to make a difference in people'slives. It is a workplace driven by integrity, one of Takeda’slong-held values that extends to both the patients we serve and ouremployees who develop and deliver medicines. Across our company,Takeda employees bring together diverse strengths that togethercreate a stronger whole.

As one of the world’s leading biopharmaceutical companies,Takeda is committed to bringing Better Health and a Brighter futureto people worldwide. We aspire to bring our leadership intranslating science into life-changing medicines to the next level,in our core focus areas; oncology, gastroenterology, neuroscience,rare diseases, plasma-derived therapies, and vaccines. The GreaterBoston Area is headquarters to many of our Global and US businessunits.

We are a passionate team doing important work that impactspatients’ lives. If you are driven to create better health and abrighter future, join us!

Success What makes a successful member of our team? Check outthe traits we’re looking for and see if you have the right mix.

Life at Takeda A Global Top Employer Recognized for our cultureand way of working, we’re one of only select companies to receiveTop Global Employer ® status for 2020.

Associate Director, Advanced Analytics, Cell Therapy Job IDR0022442 Date posted 08/31/2020 Location Cambridge,Massachusetts

Are you looking for a patient-focused company that will inspireyou and support your career? If so, be empowered to take charge ofyour future at Takeda. Join us as an Associate Director, Advancedanalytics, Cell Therapy, in our Cambridge office.

As an Associate Director working on the Cell Therapy Analyticsteam, you will be empowered to drive advanced characterization andcritical quality attribute analysis related to Cell therapyproducts.

POSITION OBJECTIVES:

Accountable for the leadership of the Cell Therapy analyticaldevelopment team, including defining its vision, strategy,execution, hiring, training, staff assignment, coaching, mentoringand performance management.

Accountable for analytical development capabilities buildup andintegrating analytical methods into early stage clinicalmanufacturing, product release testing, and productcharacterization.

Responsible for the successful transfer of early phase analyticsfrom biotech and academic partners or internal programs.

Accountable for developing and executing Cell Therapy CMCstrategies to enable and deliver IND and BLA filings.

Responsible for establishing operating budgets and managingexpenses within those budgets Takeda’s Cell Therapy Analytics teamis seeking an Associate Director to have overall responsibility forleading and managing advanced analytics for cell therapy pipelines,which includes but not limited to advanced analytical platformevaluation and implementation, deep characterization of celltherapy products and CQA correlative studies. The ideal candidatewill also assume a key leadership role in the development ofanalytical strategies for cell therapy pipelines.

POSITION ACCOUNTABILITIES:

Provide strategic, technical and scientific leadership to CellTherapy analytical development team

Accountable for advanced analytical capabilities buildup andteam management

Lead and manage analytical activities for extendedcharacterization of cell therapy products

Oversee product CQA study plan, execution and data analysis

Review/approve technical reports, controlled clinicalmanufacturing sample analysis documents (e.g., analytical methodsand associated protocols, SOPs, etc.) and incorporate regulatorydocuments.

Accountable for developing and executing Cell Therapy CMCstrategies to enable and deliver IND and BLA filings.

Collaborate closely with other key line functions andcommunicates complex data/decisions within department and crossfunctionally

Responsible for integrating scientific/technical efforts aroundcross-functional issues

EDUCATION, EXPERIENCE AND SKILLS:

Advanced degree (PhD highly desirable) in relevant scientificdiscipline (such as Biotechnology, Immunology, Molecular Biology,Biochemistry, Bioinformatics) with minimum 7 years of relevantindustry experiences.

Excellence and successful track record in leadership, peoplemanagement and managing interfaces with other functions andintegrated teams.

Proven track record and demonstrated deep understanding ofpharmaceutical drug development, program and projectdevelopment.

Significant prior experience in driving characterization of celland gene therapy products and correlative studies for product CQAdiscovery

Deep understanding in advanced analytical platforms and relateddata analysis, e.g. RNAseq, 20+ flow cytometry and/or single cellanalytical assays

Knowledge of clinical manufacturing sample management andanalysis plan

Prior experiences in cell products in vivo characterization is abig plus

Understanding of various cell and gene therapies, gene editingtechnologies with previous experience in CAR T or CAR NKproducts

Prior experience with IND, NDA or BLA desirable

Check out where you could be

working if you apply.

Job Seekers: Protect yourself against identity theft Please beaware there are instances of identity thieves postingTakeda-branded jobs and posing as employees to steal personalinformation. They visit job-related websites and invite candidatesto online chats. During the chat, they press job seekers to providebank account information and Social Security numbers.

Copyright 1995-2019 Takeda Pharmaceutical Company Limited. Allrights reserved.

Keywords: Takeda Pharmaceuticals International GmbH, Cambridge , Associate Director, Advanced Analytics, Cell Therapy, Other , Cambridge, Massachusetts

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Keywords: Amazon Workforce Staffing, Cambridge , Associate Director, Other , Cambridge, Massachusetts

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