Associate Director, Analytical Development and Operations, C

Company: Takeda Pharmaceuticals International GmbH
Location: Boston
Posted on: February 25, 2021

Job Description:

The health and safety of our employees and candidates is very important to us. Due to the current situation related to the Coronavirus (COVID-19), we're leveraging our digital capabilities to ensure we can continue to recruit top talent at Takeda. As your application progresses, you may be asked to use one of our digital tools to help you through your recruitment journey. If so, one of our colleagues will explain how these tools will be used during the recruitment process. Thank you. *Please be aware of an Identity Theft Scheme targeting individuals seeking jobs with Takeda and other employers. See below or here for more info. Associate Director, Analytical Development and Operations, Cell Therapy Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda's long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole. As one of the world's leading biopharmaceutical companies, Takeda is committed to bringing Better Health and a Brighter future to people worldwide. We aspire to bring our leadership in translating 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 Greater Boston Area is headquarters to many of our Global and US business units. We are a passionate team doing important work that impacts patients' lives. If you are driven to create better health and a brighter future, join us! Success What makes a successful member of our team? Check out the traits we're looking for and see if you have the right mix. Life at Takeda A Global Top Employer Recognized for our culture and way of working, we're one of only select companies to receive Top Global Employer -- status for 2021. Associate Director, Analytical Development and Operations, Cell Therapy Job ID R0022622 Date posted 02/01/2021 Location Boston, Massachusetts 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 an Associate Director, Analytical Development and Operations, Cell Therapy, in our Cambridge office. As an Associate Director working on the Cell Therapy Analytics team, you will be empowered to drive advanced analytical method development and QC activities related to Cell therapy products. POSITION OBJECTIVES: Accountable for the leadership of the Cell Therapy analytical development team, including defining its vision, strategy, execution, hiring, training, staff assignment, coaching, mentoring and performance management. Accountable for analytical development capabilities buildup and integrating analytical methods into early stage clinical manufacturing, product release testing, and product characterization. Responsible for the transfer of analytical methods from/to CROs and/or monitoring the testing and/or methods internal transfer globally. Accountable for developing and executing Cell Therapy CMC strategies to enable and deliver IND and BLA filings. Responsible for establishing operating budgets and managing expenses within those budgets. Takeda's Cell Therapy Analytics team is seeking an Associate Director to have overall responsibility for leading and managing analytical methods for cell therapy pipelines, which includes but not limited to analytical methods development, qualification and tech-transfer; working with CRO/CDMO for tech-transfer and product testing. The ideal candidate will also assume a key leadership role in the development of analytical strategies for cell therapy pipelines.-- POSITION ACCOUNTABILITIES: Provide strategic, technical and scientific leadership to Cell Therapy analytical development team Accountable for analytical capabilities buildup and team management; Lead and manage analytical activities internal and externally, execution and data analysis Review/approve technical reports, controlled clinical manufacturing sample analysis documents (e.g., analytical methods and associated protocols, SOPs, etc.) and incorporate regulatory documents. Accountable for developing and executing Cell Therapy CMC strategies to enable and deliver IND and BLA filings. Collaborate closely with other key line functions and communicates complex data/decisions within department and cross functionally Responsible for integrating scientific/technical efforts around cross-functional issues EDUCATION, EXPERIENCE AND SKILLS: Advanced degree (PhD highly desirable) in relevant scientific discipline (such as Biotechnology, Immunology, Molecular Biology, Biochemistry, Bioinformatics) with minimum 7 years of relevant industry experiences. Excellence and successful track record in leadership, people management and managing interfaces with other functions and integrated teams. Proven track record and demonstrated deep understanding of pharmaceutical drug development, program and project development. Significant prior experience in driving method development for cell and gene therapy products and Deep understanding analytical platforms, e.g. flow, ELISA, PCR and cell based assays; Prior experiences in GMP QC environment is a big plus; Understanding of various cell and gene therapies, gene editing technologies with previous experience in CAR T or CAR NK products; Prior experience with IND, NDA or BLA desirable TRAVEL REQUIREMENTS: May require approximately 15% travel. Check out where you could be
working if you apply. Job Seekers: Protect yourself against identity theft Please be aware there are instances of identity thieves posting Takeda-branded jobs and posing as employees to steal personal information. They visit job-related websites and invite candidates to online chats. During the chat, they press job seekers to provide bank account information and Social Security numbers. Copyright 1995-2019 Takeda Pharmaceutical Company Limited. All rights reserved.

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