Principal Scientist, Global DMPK

Company: Takeda Pharmaceuticals International GmbH
Location: Cambridge
Posted on: April 5, 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. 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. Job ID R0024420 Date posted 01/12/2021 Location Boston, Massachusetts Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Principal Scientist, Global DMPK in our Cambridge office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. OBJECTIVES: The new hire will be part of the bioanalytical group within the global DMPK department residing at 35 Landsdowne St, Cambridge, MA. We are seeking a highly experienced and motivated individual with in-depth knowledge and excellent skills in supporting multiple modalities (e.g., small molecules, biologics, ASOs, nanomedicines, gene/cell therapies, etc) in multiple therapeutic areas. The individual is expected to have an impressive record of accomplishments and publications in the bioanalysis and/or related areas and have extensive knowledge in the area of drug development, assay development and troubleshooting, and regulatory compliance of bioanalytical studies. The position is expected to interact with key internal stakeholders such as Global DMPK and DSRE project representatives, QTS groups, and Drug Discovery Units (DDUs), to perform innovative bioanalytical method development via internal and/or external resources, effectively troubleshoot scientific issues, and advance projects for submissions within timelines. The individual must have extensive experience in working with CROs as a scientific and compliance monitor. ACOUNTABILITIES:

• Serve as the lead bioanalytical scientist on development projects to interact with Global DMPK and DSRE representatives, PTS Operation, Reagent Sourcing, QTS, QA and other pertinent study personnel.
• Effectively c ommunicate with the internal stakeholders regarding the project advancement and study plan, assay needs, method transfer and adoption, study progress updates, and DMPK bioanalytical deliverables. Plan study activities to meet the established timelines. Prioritize and re-prioritize activities as needed to deal with unanticipated, urgent and long term requests.
• Serve as the scientific and compliance monitor for bioanalytical studies outsourced at CROs for supporting preclinical developmental and translational research. Anticipate and mitigate potential technical and resource issues and bottlenecks.
• Oversee method transfer/adoption, development/re-development, qualification/validation/cross-validation, and study report. Assist in managing CRO sample and data flow logistics as necessary.
• Summarize and present the experimental result in the cross-functional project team, BA group and DMPK department meetings. Proactively identify opportunities for updating professional skills on both scientific and regulatory compliance aspects through training or participating in conferences. Highly encouraged to contribute in external presentations and publications.
• Actively follow the trend of the industry and seek novel solutions to meet assay needs. Develop and/or adopt new technologies for addressing the new scientific challenges in project support. Mentor junior scientists in the group as necessary. EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
  • The applicant must have a Ph.D. in chemistry, biology, biochemistry/pharmacology/life other related fields with a minimum of 8 years of relevant industry research experience, or MS with 18+ or BS with 20+ years' experience. Supervisory experience is highly preferred.
  • Must have excellent technical expertise with hands-on experience and deep knowledge in a wide scope of bioanalytical assays including but not limited to mass spectrometry assay, ligand binding assay, immunogenicity and genomic assay. Must be a subject area expert in at least one of the areas mentioned above with a proven record of publications.--
  • Must have expertise in regulatory sciences and is familiar with the relevant regulatory guidance and industrial practices on bioanalysis for supporting new modalities.
  • She or he must demonstrate ability to solve complex scientific problems and to work as a leader or a member within a matrix and team environment
  • Must be well organized with excellent inter-personal skills and oral and written communication capabilities for working in a dynamic team environment and mentoring junior scientists with collaborative mindsets. 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 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.

Keywords: Takeda Pharmaceuticals International GmbH, Cambridge , Principal Scientist, Global DMPK, Other , Cambridge, Massachusetts