Systems Analyst II

4 days ago

Waltham, United States Alkermes Full time
Job Description

Company Overview:

Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com. This role is a hybrid role in our Waltham location.

POSITION SUMMARY:
  • Alkermes is seeking a Systems Analyst II to join the R&D IT 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 Electronic Lab Notebook (ELN) and Empower Chromatography Data Software (CDS) applications.
  • A strong background in databases, web-based and client-server applications, and some programming/development skills are desirable.
  • Lead and coordinate, technical and business discussions to understand customer needs as related to R&D
  • The experienced candidate will work with business partners, quality representatives, as well as IT representatives to help develop user requirements, 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.
  • Some of the work of the Senior Systems Analyst is conducted within regulatory guidelines and industry best practices.
  • Must have previous experience working in GxP labs. Have worked on qualifying new lab systems per 21 CFR Part 11 requirements.
Responsibilities

ESSENTIAL AREAS OF RESPONSIBILITY:
  • Collaborate with R&D business functions (e.g. Research, Analytical Development, Process Development, Formulation Development), IT Infosec/Infrastructure, and QA/Validation to identify and implement IT solutions to meet business needs
  • Manage small-scale projects to develop, test, and release enhancements across lab automation systems at Alkermes
  • Work closely with our internal teams to facilitate refactoring of internal platforms leveraging tools such as Docker, AWS microservices, Kubernetes, Informatica, Snowflake, etc.
  • Configure Waters ELN to meet user requirements in GxP regulated environments
  • Responsible for operational support of lab systems within R&D labs e.g. HPLCs, Imaging systems, balances, microscopes
  • Responsible for creating and maintaining system life cycle documentation within Quality Management Systems including but not limited to: Validation Specifications, SOPs, URS, and User Acceptance Testing (UAT)
  • 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

BASIC 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 working in a regulatory GxP laboratory.
  • 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
Technical Knowledge/Skills Needed:
  • Practical knowledge of Electronic Laboratory Notebooks, data visualization platforms, 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
  • Practical knowledge of 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
  • Strong experience in managing technical deliverables using agile methodology and Kanban boards
  • Be able to analyze and develop architectural requirements, and to align those requirements with system and hardware development strategy.
PREFERRED QUALIFICATIONS:

Personal Attributes Needed:
  • Able to be self-directed, within the framework of IT and corporate policies, and to thrive in a distributed environment, working independently and/or with small teams, and with limited support
  • Displays flexibility and creativity in problem solving and meeting 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 organized individual
  • Influences, listens & values/recognizes all opinions and represents IT in a diplomatic way facilitating open discussion across all functions
  • Able to thrive in a highly collaborative environment; self-starter, energizing, and results oriented.
  • Must be able to work in the Waltham office in a Hybrid office schedule


#LI-TS1

About Us

Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.

Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee 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 characteristic protected by local, 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.

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