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LBP (Microbiome)Senior Scientist

Cambridge, Massachusetts


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LBP (Microbiome)Senior Scientist

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Job ID SR0051987 Date posted 09/29/2020 Location Cambridge, Massachusetts

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

As a Senior Scientist working as part of Analytical Development supporting LBP products you will be able to make an impact in the ability for innovation, provide technical leadership and oversee outsourced programs.

Responsibilities include:

  • Development of assays for release and characterization testing to support microbiome programs (i.e. molecular, FACS, viable titer, live/dead screening)
  • Design and participate in phase appropriate validations and transfer of LBP methods
  • Author, review and/or approve technical documents or regulatory filings ensuring high technical standards and compliance with applicable regulatory guidelines to support LBP products.  (protocols, reports, test methods, regulatory filings, etc)
  • Evaluation / Implementation of new technologies
  • Manage outsourced activities pertaining to LBP development, validation and testing
  • Sample testing to support process and formulation development

Responsibilities Breakdown:

  • 50%: Planning, designing, and conducting experiments and data analysis to support the development and optimization of LBP methods
    • Responsible for documentation of experimental data, generation of high-quality written study protocols, development reports, and oral presentations
  • 30% :Design and participate in the qualification and transfer strategy of analytical impurity methods to support LBP product release.
    •  Responsible for execution and documentation of qualification data, generation of high-quality written study protocols, qualification reports, and leading cross functional meetings
  • 20% :Manage outsourced activities pertaining to LBP development, validation and testing

Key Skills & Competencies:

  • Develops complex strategic approaches and methodologies within expertise with an understanding of how to weigh and assess technical risks.  Leverage understanding of project timelines and big picture (e.g., impact on resources, legal, IP, across functions in Pharm Sci).
  • Develops technical skill(s) to act as a resource/expert for the department.
  • Responsible for authoring and/or reviewing technology transfer documentation, PS sections of regulatory documents, or validation plans and reports within expertise
  • Identifies and plans broader technical objectives both project and scientific related and executes plans independently or with input from management. Initiates the development of operational processes to facilitate these objectives for future projects, either independently or in consultation with manager.
  • Proactively builds relationships with key partners/stake holders to gain access to technologies/understanding and deliver on pipeline goals.
  • Responsible for coordinating cross-functional team and providing resolutions to scientific/technical challenges. Expected to fully represent their functional area to a PS sub-team or other cross functional team.
  • Develops the ability to define more complex/novel approaches and methodologies to solve complex technical challenges.   
  • Knowledgeable in multiple functional areas to advise a PS team on potential impacts of team actions.  Coordinates with cross functional peers and evaluates the impact of decisions.
  • Contributes to departmental operational strategies and participates on initiatives in a cross departmental capacity and across sites. Assists with the operations of the group and department such as resource planning, process improvements, infrastructure, and initiatives.
  • Keeps abreast of literature and benchmark best practices outside the company
  • Expertise in multiple technologies to support assay development of LBP products
  • May represent Takeda in relationships with universities and industrial consortia
  • Makes significant independent contributions to complex/multiple projects or functional area through leading or influencing others
  • Manages externalized activities such as: method development and phase appropriate validation

Complexity and Problem Solving

  • In-depth understanding of relevant guidelines (ICH, EU, LBP regulatory guidance’s)
  • In depth knowledge of theories/principles of microbiological techniques such as microscopy, anaerobic culturing, ddPCR, qPCR, sequencing, MALDI-TOF, Karl Fisher and flow cytometry
  • Lead method development, qualification, and technology transfer activities
  • Identify and analyze technical problems and proactively explore/implement solutions
  • Independently plan, design, execute, and analyze experimental data and provide succinct conclusions and/or recommendations
  • Work closely with his/her supervisor and coworkers in managing multiple work streams and projects. Make sound and timely decisions based on project priorities. Provide expert input to internal and external sub-teams.

Required Education and Skills:

Degree in Microbiology, Biology, Biochemistry or other related discipline with minimum to some years of relevant industry experiences in analytical development.

  • Ph.D. with 3+ years of relevant postdoctoral or industry experience.
  • MS with a minimum of 9+ years relevant industry experience.
  • BS with a minimum of 11+ years relevant industry experience.
  • Must have experience with microbiological techniques such as microscopy, anaerobic culturing using aseptic technique, ddPCR, qPCR, familiarity with sequencing (16s, WGS, NGS), MALDI-TOF, Karl Fisher, flow cytometry, FACS and biochemical ID (i.e. Vitek-MS).
  • The candidate must be knowledgeable with ICH, EU and emerging LBP regulatory guidance’s including the adaptation of USP 61/62
  • Proven record of technical expertise and troubleshooting. Proven ability to work in a fast-paced environment with demonstrated capacity to juggle multiple competing tasks and demands.
  • Effective communication skills (oral and written) are essential.

Other Job Requirements

  • Flexibility to work between two sites (Cambridge / Lexington) may occasionally be required.
  • Some domestic travel may be required to work with external partners.

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.

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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 SR0051987

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