Principal Scientist, Digital Scientist, CMC, Pharmaceutical Sciences

JPN - Kanagawa - iPark, Japan

Takeda

Takeda is a patient-focused, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future.

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Job Description

Takeda is unwavering in our commitment to patients. With the patient at the center of everything we do, we continue to innovate and drive changes that will better their lives - we’re looking for like-minded professionals to join us.

Takeda is a global industry leader –we are united by our four priorities (Patients, Trust, Reputation, and Business) and our shared values of Takeda-ism: Integrity, Fairness, Honesty, and Perseverance. Takeda-ism is more than just a word. It’s a belief and a mindset which guides our decisions, behaviors, and interactions. It’s how we strive to work and live, every day.

About the Role

  • Support an In Silico First paradigm in Pharm Sci by building & supporting the deployment of industry-leading smart algorithms & predictive models (both statistical & first principle) to support optimization of control loops, platform performance & CMC workflows to advance pipeline programs.
  • Support & implement lab & pilot-scale platforms, collect & analyzes structured & unstructured data of product & process and generates scientific reports including conclusions & recommendations
  • Be recognized as a technical resource & expert across PharmSci and the broader R&D community for mathematical modeling, harnessing next generation capabilities in the field of Data Science and utilization of his/ her technical expertise to contribute across multiple projects and drive technical & scientific strategy
  • Lead and undertake scientific research, complex troubleshooting & problem-solving activities; able to do so while applying Machine/Deep Learning
  • Keep abreast of technological advances specific to Digital Acceleration, Data Science, Data Engineering, Computational Process Development, Systems Biology, and Advanced Process Control.
  • Support the In Silico First initiative by representing the PSST team while interacting with different functions as a business and technical expert, providing scientific support to the respective functional area & communicating central guidance & support from the global suites to the local teams

ACCOUNTABILITIES

  • Support projects, primarily within a framework of the In-Silico First (ISF) initiative via the following:
  • Review, interpret and communicate data cross-functionally across PharmSci and project teams
  • Perform or support the performance of Statistic/Machine/Deep Learning and other advanced data techniques in support of ISF PoCs towards deriving better insights from available datasets
  • Understand and use different Supervised and Unsupervised learning techniques, their biases, how and when to apply them and which methods are the best for a particular analysis
  • Wrangle raw data sets or provide data management guidance about data cleaning, such that data is translated into a format that can have advanced methods applied against the resulting data
  • Maintain responsibility for collaborating with all functions in PharmSci and other divisions to encourage strategic alignment and successful achievement of shared goals, particularly as it pertains to ISF. Leverages technical skill(s) as a resource/expert across PharmSci
  • Contribute significantly and independently to project work, which may include multiple projects within a functional area
  • Plan and implement resolutions to technical problems/issues, recommend and implements technologies and innovations
  • Own a discipline/technical skill in its entirety and continues to develop expertise in other key technical skills
  • In collaboration with commercial functions, develop and implement strategies to control quality of drug substances and products based on the current GxP regulations
  • Responsible for authoring relevant sections of regulatory documents, report and peer-reviewed manuscripts
  • Proactively identify vendors and build relationships to gain access to technologies as needed to deliver on pipeline goals.
  • Act as a technical leader for emerging digital capabilities

Requirements: 

  • Bachelors degree in Data Science, Statistics, Bio-Informatics, Mathematics, Chemometrics, Chemistry, Biology, Engineering or related pharmaceutical science and 11+ years relevant industry experience, or
  • Masters degree in Data Science, Statistics, Bio-Informatics, Mathematics, Chemometrics, Chemistry, Biology, Engineering or related pharmaceutical science 9+ years relevant industry experience, or
  • PhD in Data Science, Statistics, Bio-Informatics, Mathematics, Chemometrics, Chemistry, Biology, Engineering or related pharmaceutical science and 3+ years relevant industry experience
  • Solid understanding of current Good Manufacturing Practices (cGMP) is preferred
  • Experience in working in a multi-disciplinary team environment
  • Experience in the use of mathematical, both statistical and first principle, models as well as advanced process control systems
  • Solid knowledge of the pharmaceutical industry and its R&D
  • Experience in writing regulatory documents
  • Sound knowledge of current GxP
  • Comfortable working in the according Data Science environment: using frameworks (e.g. Python, MATLAB, R, JMP), considering industrial Data Engineering protocols (e.g. OPC, Modbus) and repositories (e.g. SQL, Oracle, AWS)
  • Ability to analyze a wide variety of information and data to make management decisions regarding potential risks associated with product quality and regulatory compliance.
  • Demonstratable critical and out-of-the-box thinking ability
  • Understanding of the structure, functions, and methods of the global Takeda organization and overall Takeda R&D operations.
  • Excellent organizational and communication skills. Develops and maintains relationships with colleagues within manufacturing and research networks to identify & support potential value-creating opportunities. Demonstrates ability to negotiate difficult issues and arrive at mutually beneficial solutions
  • Proven scientific track record through presentations at scientific conferences and publication of peer-reviewed manuscripts
  • Some experience in Project Management

Takeda Compensation and Benefits Summary:

  • Allowances: Commutation, Housing, Overtime Work etc.

  • Salary Increase: Annually, Bonus Payment: Twice a year

  • Working Hours: Headquarters (Osaka/ Tokyo) 9:00-17:30, Production Sites (Osaka/ Yamaguchi) 8:00-16:45, (Narita) 8:30-17:15, Research Site (Kanagawa) 9:00-17:45

  • Holidays: Saturdays, Sundays, National Holidays, May Day, Year-End Holidays etc. (approx. 123 days in a year)

  • Paid Leaves: Annual Paid Leave, Special Paid Leave, Sick Leave, Family Support Leave, Maternity Leave, Childcare Leave, Family Nursing Leave.

  • Flexible Work Styles: Flextime, Telework

  • Benefits: Social Insurance, Retirement and Corporate Pension, Employee Stock Ownership Program, etc.

Important Notice concerning working conditions:

  • It is possible the job scope may change at the company’s discretion.

  • It is possible the department and workplace may change at the company’s discretion.

Locations

Fujisawa, Japan

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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Perks/benefits: Career development Conferences Equity / stock options Flex hours Salary bonus Team events

Region: Asia/Pacific
Country: Japan

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