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Sr Scientist, Digital CMC

Lexington, Massachusetts

Overview

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.

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!

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What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Collaborative
  • Strategic
  • Results Driven
  • Self-starter
  • Versatile
  • Team player

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Opportunity

  • Since 1781, the values of Takeda-ism (Integrity, Fairness, Honesty, and Perseverance) have guided everything we do—from decision-making to interacting with patients.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.

  • Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Our vision is of a world with accessible healthcare for all, where prevention measures are exponentially advanced and billions are freed of disease. Our approach is rooted in our patient-centricity and the creation of outstanding treatments that change people's lives. Building upon a foundation of sustainability, we are committed to contributing to the long-term health of people through disease prevention.

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Sr Scientist, Digital CMC

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Job ID SR0049403 Date posted 06/10/2020 Location Lexington, Massachusetts

Takeda is looking for a Scientist to join our Innovation & Technology Sciences Team in Pharmaceutical Sciences, R&D. We are looking for a Leader who can use their Mathematics, Machine Learning, Deep Learning and Advanced Analytics skills to help deliver insights for our most difficult questions.  You will work with the rest of the global PharmSci team to enable Takeda to continue its journey of therapy development, manufacturing process automation, data maturity, delivering outputs while educating others.  You will be helping to solve some of the biggest question at Takeda and for healthcare in general.

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as in our Lexington or Cambridge, MA location.

OBJECTIVES:  

  • He/ She builds & deploys industry-leading smart algorithms & predictive models (both statistical & first principle) to support to optimization of control loops, platform performance & CMC workflows to advance pipeline programs and innovation initiatives.
  • He/ She implements lab & pilot-scale platforms, collects & analyzes structured & unstructured data of product & process and generates scientific reports including conclusions & recommendations.  
  • He/She undertakes scientific research, complex troubleshooting & problem-solving activities applying Machine/Deep Learning.
  • He/ She is 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.
  • He/ She keeps abreast of technological advances specific to Digital Acceleration, Data Science, Data Engineering, Computational Process Development, Systems Biology, and Advanced Process Control.

ACCOUNTABILITIES:  

  • Reviews, interprets and communicates data cross functionally within PharmSci and project teams.
  • Performs Machine/Deep Learning and other advanced data techniques for the purpose of deriving better insights from available datasets.
  • Understands and uses different Supervised and Unsupervised learning techniques, their biases, how and when to apply them and which methods are the best for a particular analysis.
  • Able to wrangle raw data sets into a format that can have advanced methods applied against the resulting data.
  • Responsible for collaborating with other functions in PharmSci to encourage strategic alignment and successful achievement of shared goals. Leverages technical skill(s) as a resource/expert across PharmSci.
  • Contributes significantly and independently to project work which may include multiple projects within functional area.
  • Plans and implements resolutions to technical problems/issues, recommends and implements technologies and innovations.
  • Owns a discipline/technical skill in its entirety and continues to develop expertise in other key technical skills.
  • In collaboration with commercial functions, develops and implements strategies to control quality of drug substances and products based on the current GxP regulations.
  • Responsible for authoring relevant sections of regulatory documents, reports and peer-reviewed manuscripts.
  • Proactively identifies vendors and builds relationships to gain access to technologies as needed to deliver on pipeline goals.
  • Acts as an ambassador for emerging digital capabilities

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job.  Any minimum requirements should be noted.)

  • Bachelor’s degree in Statistics, (Bio-)Informatics, IT, Chemistry, Biology, Mathematics, Engineering or related pharmaceutical science and 5+ years relevant industry experience 
  • Master’s degree in Statistics, (Bio-)Informatics, IT, Chemistry, Biology, Mathematics, Engineering or related pharmaceutical science; 3+ years relevant industry experience 
  • PhD in Statistics, (Bio-)Informatics, IT, Chemistry, Biology, Mathematics, Engineering or related pharmaceutical science; 2+ years relevant industry experience
  • 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.
  • Demonstrated management skills, critical and out-of-the-box thinking ability
  • Understands the structure, functions, and methods of the global Takeda organization and overall Takeda R&D operations.
  • Excellent organizational and communication skills.  Has the ability to influence at all levels of the organization and manage projects across businesses and the globe.  Develops and maintains relationships with colleagues within manufacturing and research networks to identify & support potential value-creating opportunities.  Demonstrated ability to negotiate difficult issues and arrive at mutually beneficial solutions
  • Experience in writing regulatory documents a plus
  • Sound knowledge of current GxP a plus
  • Experience in working in a multi-disciplinary team environment
  • Proven scientific track record through presentations at scientific conferences and publication of peer-reviewed manuscripts is a plus
  • Experience in Project Management is a plus

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Job ID SR0049403

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