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.
