Senior Systems Analyst at Alkermes, Inc.

Posted in Other 11 days ago.

Location: Waltham, Massachusetts





Job Description:

POSITION SUMMARY:


Alkermes is seeking a Senior Systems Analyst to join the Development Solutions team.


The ideal candidate can work autonomously, is energized by exploring new technology, welcomes shifting priorities, and approaches every issue as a new challenge to tackle. The experienced candidate is someone that wants to make an impact within R&D IT to support the advancement of new medicines.


This candidate will help manage several enterprise lab systems including the Waters NuGenesis ELN and Empower CDS applications. A strong background in databases, web-based and client-server applications, and some programming / development skills are desirable.


The experienced candidate will work with business partners, quality representatives, as wells as IT representatives to help develop application deployment and user acceptance test scripts, execute against validation plans, and provide day to day system administration support.


This role will have the opportunity to help build new IT processes, standards, and systems. This role requires business analysis and project management skills, as well as knowledge of business processes and applications within Life Science Research and Development.


All work of the Senior Systems Analyst is conducted within regulatory guidelines and industry best practices.


The role will be based in Waltham, MA and includes 10-20% travel.


ESSENTIAL AREAS OF RESPONSIBILITY:



  • Collaborate with R&D business functions (e.g. Analytical Development, Process Development, Formulation Development), IT Infrastructure, and QA/Validation to identify and implement IT solutions to meet current and future business needs

  • Manage small-scale projects to develop, test, and release enhancements across lab automation systems at Alkermes

  • Configure Waters ELN to meet user requirements in GxP regulated environments

  • Responsible for creating and maintaining system life cycle documentation within Quality Management Systems including but not limited to: Validation Specifications, SOPs, and UAT

  • Develop reports (tabular, trend and/or labels), database queries/scripting, data pipelines/workflows to facilitate distributed data analytics projects and programs

  • Manage system change controls via IT Change Management (e.g. ITIL) and/or GDP (e.g. SOPs, Change Controls)

  • Provide end-user support related to Global R&D applications


QUALIFICATIONS:


Minimum Education:



  • Bachelor's degree in chemistry, biology, bioinformatics, information technology,or similar discipline. Master's degree is a plus.


Experience:



  • Professional experience (5-8 years) in Biotechnology/Pharma IT Organizations; preferred experience within R&D IT roles

  • Experience with CDS, ELN, and SDMS systems

  • Experience delivering technical solutions across multiple business groups and geographical locations

  • Experience in documenting detailed requirements, user stories, business processes and technical specifications

  • Experience with SaaS / PaaS models and managed services

  • Experience in managing GxP systems


Technical Knowledge/Skills Needed:



  • Practical knowledge of Electronic Laboratory Notebooks, data visualization platforms, Manufacturing Execution Systems, Laboratory Execution Systems, and integration technologies

  • Strong organizational skills, with the ability to drive projects, meet timelines, and deliver results

  • Database management, design, and/or programming a plus

  • Waters ELN deployment, troubleshooting, and administration experience a plus

  • Basic GAMP5 and Computer System Validation strategies

  • Basic GxP, Part 11, and Annex 11 knowledge and experience working within those frameworks

  • Ability to manage technical issues and root cause analysis across various applications and tools

  • Anticipates unique customer service needs and plans support accordingly

  • Excellent communication and documentation abilities

  • Knowledge of KNIME a plus

  • AWS experience a plus


Personal Attributes Needed:



  • Able to be self-directed, within the framework of IT and corporate policies, and to thrive ina distributed environment, working independently and/or with small teams, and with limited support

  • Displays flexibility and creativity in problem solving andmeeting work assignments while ensuring compliance with policies and procedures

  • Must be highly adaptive, able to follow instructions, work independently, and function in a team as needed

  • Strong focus on customer service with the ability to understand how own contribution impacts site goals

  • Must be a quick learner and organizedindividual

  • Influences, listens & values/recognizes all opinions and represents IT in a diplomatic way facilitating open discussion across all functions.


Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.


#LI-KO1

Experience Level:
Mid-Senior Level

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