Posted to MedZilla on 8/15/2018


Takeda Pharmaceuticals

US-MA, Senior IS/IT Analyst- Vaccines Research and Preclinical R0000469-MZ


 
 

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Job Description

Objectives:

This role provides management and hands on support of IS/IT services and systems deployed in support of Takeda Vaccines Preclinical research operations globally.

Work closely with scientists, Preclinical leadership, and the IT organization to support the Lab Informatics, Research and CMCC Informatics services, including systems such as ELN, LIMS, CDS, Lab Automation, Inventory, Compound Management, Data Management and Archival.


Accountabilities:


Business Partner to the global Vaccines Pre-Clinical organization, including Analytical Development, Process Development, and Formulations Development departments

{PS..1}--> Work with scientists and scientific leadership to assess current state of informatics environment and develop a roadmap of solutions to meet needs. Sites are located in Boston, Singapore, and Japan.

Proactively partner with internal stakeholders across R&D labs to understand needs. Lead subject matter experts through the selection, implementation, and support of software systems.

{PS..2}--> Manage IT projects that deliver new and improved lab and research informatics capabilities at Takeda Vaccines, leading a team of cross functional stakeholders and managing vendor activities as necessary.

Establish and maintain strong relationships with vendors providing software, service, and support of laboratory information systems.

{PS..3}--> Working with Quality Assurance, use risk-based approaches to assess compliance impacts and build quality into systems implementation and change control activities.

Manage support of various software platforms that support lab researchers including, but not limited to:

{PS..4}-->o Electronic Lab Notebooks

{PS..5}-->o Sample Management

{PS..6}-->o Chemical, reagent, equipment Inventory

{PS..7}-->o Chromatographic Data Systems

{PS..8}-->o Laboratory Robotics

{PS..9}-->o Bioreactor controllers and historians

{PS..10}-->o Data Management and Archival

{PS..11}--> Provides input into project budgets and reporting within own area.

Follows company and departmental policies, procedures and ensures documentation according the Takeda Quality Management Systems (QMS), Software Development Life Cycle and Project Life Cycle standards.

{PS..12}--> Establishes good working relationships with colleagues within the Global IS/IT Organization (IT Infrastructure, PMO, and other solution service groups).

Required:

Bachelor s degree and 4+ years of relevant experience or Master s Degree and 2+ years relevant experience within the Pharmaceutical industry supporting early research or pre-clinical groups.

Business Analyst and/or Project management experience.

Hands on experience with laboratory software systems (LIMS, ELN, etc.) and knowledge of typical capabilities needed (raw data management, registration, inventory management, visualization and analytics, sample and inventory management)

{PS..1}--> Up to date on best in class vendor and product offerings

Experience designing, deploying and maintaining cloud-based applications

{PS..2}--> Strong interpersonal and communication skills within IT as well as with scientists.

Ability to be self-directed and work independently within the framework of the IT and cross-functional scientific organization.

{PS..3}--> Excellent oral and written communications skills, business acumen with analytical and problem solving skills.

Ability to multitask and prioritize among competing demands.

Preferred:

{PS..4}--> Familiarity with regulated systems and Software Development Lifecycle for both Non-GxP and GxP systems.

Experience working in an international environment.

{PS..5}--> Project Management Professional (PMP)

Business Analysis (IIBA or PMI)


Please visit our website at takedajobs.com

 
 


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