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.
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 withCROs as a scientific and compliance monitor.
- 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
- Community Outreach Programs
Empowering Our People to Shine
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