Digital Scientist, CMC Position Available In Suffolk, Massachusetts

Job Description:

By clicking the “Apply” button, I understand that my employmentapplication process with Takeda will commence and that theinformation I provide in my application will be processed in linewith Takeda’s Privacy Notice and Terms of Use . I further attestthat all information I submit in my employment application is trueto the best of my knowledge.

Job Description About the role:

Joinas a Digital CMC Scientist to support the planning, development andexecution of the In Sillico First Initiative within Takeda’sPharmaceutical Sciences organization. This exciting opportunity isperfect for experienced candidates who are curious, eager to learn,and open to working in a global setting on a variety of tasksrelated to data modeling, data fabric / architecture, andintegrated process development workflows in the pharmaceuticalR D context. In this role, you will work closely with theSustainable CMC and Innovation team as well as capability leadsfrom all development functional area to help establish processmodels, data structures, development workflows, and best practicesin an environment where formalized regulatory guidance is stillevolving. You will play a key role in supporting the implementationand operationalization of proof-of-concept development workflows,resulting in a paradigm shift that emphasizes In Silico methods asthe basis of reducing overall development effort.

How you willcontribute:

Support the build & deployment of industry-leading insilico predictive models (both statistical & first principle) tosupport full integration of platform performance workflows toadvance pipeline programs which fulfill In-Silico initiativedeliverables. Support the collection & analysis of structured &unstructured product & process data and generate scientific reportsincluding conclusions & recommendations. Undertake scientificresearch, complex troubleshooting & problem-solving activitiesapplying Machine/Deep Learning. Be recognized as a technicalresource & expert in PSST for mathematical modeling, harnessingnext generation capabilities in the field of Data Science andutilization of his/ her technical expertise to contribute acrossmultiple projects and drive technical & scientific strategy. Keepabreast 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 viathe following: Review, interpret & communicate datacross-functionally across PharmSci and project teams. PerformStatistical/Machine/Deep Learning and other advanced datatechniques for the purpose of deriving better insights fromavailable datasets. Understand and use different Supervised andUnsupervised learning techniques, their biases, how and when toapply them and which methods are the best for a particularanalysis. Be proficient at wrangle raw data sets into a format thatcan have advanced methods applied against the resulting data.

Responsible for collaborating with PharSci functions to encouragetechnical alignment & successful achievement of shared goals.

Leverages technical skills as a resource/expert across PharmSci.

Contribute to project work which may include multiple projectswithin functional area. Plan and implement resolutions to technicalproblems/issues, recommends and implements technologies andinnovations. Responsible for authoring relevant sections ofregulatory documents, report and peer-reviewed manuscripts.

Collaborate with vendors and build relationships to gain access totechnologies as needed to deliver on pipeline goals. Act as atechnical expert for emerging digital capabilities

MinimumRequirements/Qualifications:

Education and Experience:

Bachelorsdegree in Data Science, Statistics, Bio-Informatics, Mathematics,Chemometrics, Chemistry, Biology, Engineering or relatedpharmaceutical science and 8 years relevant industry experience, orMasters degree in Data Science, Statistics, Bio-Informatics,Mathematics, Chemometrics, Chemistry, Biology, Engineering orrelated pharmaceutical science 6 years relevant industryexperience, or PhD in Data Science, Statistics, Bio-Informatics,Mathematics, Chemometrics, Chemistry, Biology, Engineering orrelated pharmaceutical science and 0 years relevant industryexperience Technical Skills Experience in the use of mathematical,both statistical and first principle, models as well as advancedprocess control systems Solid knowledge of the pharmaceuticalindustry and its R D Comfortable working in the according DataScience 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 analyzea wide variety of information and data to make management decisionsregarding potential risks associated with product quality andregulatory compliance. Sound knowledge of current GxP Provenscientific track record through presentations at scientificconferences and publication of peer-reviewed manuscripts Someexperience in

Project Management Communication & Leadership Skills:

Experience in working in a multi-disciplinary team environmentDemonstratable critical and out-of-the-box thinking abilityUnderstanding of the structure, functions, and methods of theglobal Takeda organization and overall Takeda R D operations.

Excellent organizational and communication skills. Develops andmaintains relationships with colleagues within manufacturing andresearch networks to identify & support potential value-creatingopportunities. Demonstrates ability to negotiate difficult issuesand arrive at mutually beneficial solutions Robust communicationskills are necessary for explaining complex concepts and policiesacross all organizational levels and to external stakeholders. Thisalso includes the ability to mentor teams on knowledge and datagovernance standards and practices.

Regulatory Knowledge:

Understanding of cGMP requirements, and some experience withpharmaceutical regulatory documents Familiarity with recentregulatory guidance on the use of models for new drug productionapplications Knowledge of current and upcoming regulatoryrequirements around data modeling, data integrity, includingcomprehensive understanding of ALCOA principles

LeadershipBehaviors:

Candidates must demonstrate Takeda’s core leadershipbehaviors—integrity, accountability, collaboration, and innovation.

This includes maintaining ethical standards, taking proactiveresponsibility for data outcomes, effectively collaborating acrossdiverse teams, and continually seeking innovative approaches toenhance data governance.

Problem-Solving Skills:

Strong analyticaland problem-solving skills are essential for identifying andaddressing issues, developing effective solutions, and implementingchanges that enhance data integrity and operational efficiency.

More about us: At Takeda, we are transforming patient care throughthe development of novel specialty pharmaceuticals and best inclass patient support programs. Takeda is a patient-focused companythat will inspire and empower you to grow through life-changingwork. Certified as a Global Top Employer, Takeda offers stimulatingcareers, encourages innovation, and strives for excellence ineverything we do. We foster an inclusive, collaborative workplace,in which our teams are united by an unwavering commitment todeliver Better Health and a Brighter Future to people around theworld. This position is currently classified as “hybrid” followingTakeda’s Hybrid and Remote Work policy. Takeda Compensation andBenefits Summary We understand compensation is an important factoras you consider the next step in your career. We are committed toequitable pay for all employees, and we strive to be moretransparent with our pay practices.

For Location:

Boston, MA U.S.

Base Salary Range:

$111,800.00 – $175,670.00 The estimated salaryrange reflects an anticipated range for this position. The actualbase salary offered may depend on a variety of factors, includingthe qualifications of the individual applicant for the position,years of relevant experience, specific and unique skills, level ofeducation attained, certifications or other professional licensesheld, and the location in which the applicant lives and/or fromwhich they will be performing the job.

The actual base salaryoffered will be in accordance with state or local minimum wagerequirements for the job location. U.S. based employees may beeligible for short-term and/or long-termincentives. U.S.basedemployees may be eligible to participate in medical, dental, visioninsurance, a 401(k) plan and company match, short-term andlong-term disability coverage, basic life insurance, a tuitionreimbursement program, paid volunteer time off, company holidays,and well-being benefits, among others. U.S.based employees are alsoeligible to receive, per calendar year, up to 80 hours of sicktime, and new hires are eligible to accrue up to 120 hours of paidvacation. EEO Statement Takeda is proud in its commitment tocreating a diverse workforce and providing equal employmentopportunities to all employees and applicants for employmentwithout regard to race, color, religion, sex, sexual orientation,gender identity, gender expression, parental status, nationalorigin, age, disability, citizenship status, genetic information orcharacteristics, marital status, status as a Vietnam era veteran,special disabled veteran, or other protected veteran in accordancewith applicable federal, state and local laws, and any othercharacteristic protected by law. Locations Boston, MA Worker TypeEmployee Worker Sub-Type Regular Time Type Full time Job Exempt YesIt is unlawful in Massachusetts to require or administer a liedetector test as a condition of employment or continued employment.

An employer who violates this law shall be subject to criminalpenalties and civil liability.