Digital Scientist, CMC

Company: Initial Therapeutics, Inc.
Location: Boston
Posted on: May 8, 2025

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda'sand . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout the role:Join as a Digital CMC Scientist to support the planning, development and execution of the In Sillico First Initiative within Takeda's Pharmaceutical Sciences organization. This exciting opportunity is perfect for experienced candidates who are curious, eager to learn, and open to working in a global setting on a variety of tasks related to data modeling, data fabric / architecture, and integrated process development workflows in the pharmaceutical R&D context.
In this role, you will work closely with the Sustainable CMC and Innovation team as well as capability leads from all development functional area to help establish process models, data structures, development workflows, and best practices in an environment where formalized regulatory guidance is still evolving. You will play a key role in supporting the implementation and operationalization of proof-of-concept development workflows, resulting in a paradigm shift that emphasizes In Silico methods as the basis of reducing overall development effort.How you will contribute:

• Support the build & deployment of industry-leading in silico predictive models (both statistical & first principle) to support full integration of platform performance workflows to advance pipeline programs which fulfill In-Silico initiative deliverables.
• Support the collection & analysis of structured & unstructured product & process data and generate scientific reports including conclusions & recommendations.
• Undertake scientific research, complex troubleshooting & problem-solving activities applying Machine/Deep Learning.
• Be recognized as a technical resource & expert in PSST 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.
• Keep abreast of technological advances specific to Digital Acceleration, Data Science, Data Engineering, Computational Process Development, Systems Biology, and Advanced Process Control.
• Support projects, primarily within a framework of the In-Sillico First initiative via the following: Review, interpret & communicate data cross-functionally across PharmSci and project teams. Perform Statistical/Machine/Deep Learning and other advanced data techniques for the purpose of 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. Be proficient at wrangle raw data sets into a format that can have advanced methods applied against the resulting data.
• Responsible for collaborating with PharSci functions to encourage technical alignment & successful achievement of shared goals. Leverages technical skills as a resource/expert across PharmSci.
• Contribute to project work which may include multiple projects within functional area.
• Plan and implement resolutions to technical problems/issues, recommends and implements technologies and innovations.
• Responsible for authoring relevant sections of regulatory documents, report and peer-reviewed manuscripts.
• Collaborate with vendors and build relationships to gain access to technologies as needed to deliver on pipeline goals.
• Act as a technical expert for emerging digital capabilitiesMinimum Requirements/Qualifications:Education and Experience:
  • Bachelors degree in Data Science, Statistics, Bio-Informatics, Mathematics, Chemometrics, Chemistry, Biology, Engineering or related pharmaceutical science and 8+ years relevant industry experience, or
  • Masters degree in Data Science, Statistics, Bio-Informatics, Mathematics, Chemometrics, Chemistry, Biology, Engineering or related pharmaceutical science 6+ years relevant industry experience, or
  • PhD in Data Science, Statistics, Bio-Informatics, Mathematics, Chemometrics, Chemistry, Biology, Engineering or related pharmaceutical science and 0+ years relevant industry experienceTechnical Skills
    • 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
    • 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.
    • Sound knowledge of current GxP
    • Proven scientific track record through presentations at scientific conferences and publication of peer-reviewed manuscripts
    • Some experience in Project ManagementCommunication & Leadership Skills:
      • Experience in working in a multi-disciplinary team environment
      • 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
      • Robust communication skills are necessary for explaining complex concepts and policies across all organizational levels and to external stakeholders. This also includes the ability to mentor teams on knowledge and data governance standards and practices.Regulatory Knowledge:
        • Understanding of cGMP requirements, and some experience with pharmaceutical regulatory documents
        • Familiarity with recent regulatory guidance on the use of models for new drug production applications
        • Knowledge of current and upcoming regulatory requirements around data modeling, data integrity, including comprehensive understanding of ALCOA++ principlesLeadership Behaviors:
          • Candidates must demonstrate Takeda's core leadership behaviors-integrity, accountability, collaboration, and innovation. This includes maintaining ethical standards, taking proactive responsibility for data outcomes, effectively collaborating across diverse teams, and continually seeking innovative approaches to enhance data governance.Problem-Solving Skills:
            • Strong analytical and problem-solving skills are essential for identifying and addressing issues, developing effective solutions, and implementing changes that enhance data integrity and operational efficiency.More about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.This position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy.Takeda Compensation and Benefits SummaryWe understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.For Location:Boston, MAU.S. Base Salary Range:$111,800.00 - $175,670.00The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.EEO StatementTakeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob ExemptYesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
              #J-18808-Ljbffr

Keywords: Initial Therapeutics, Inc., Medford , Digital Scientist, CMC, Other , Boston, Massachusetts