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Scientific System Specialist

Req ID #:  36259
Location: 

Worcester, MA, US, 01605

For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work e perform. In return, we’ll help you build a career that you can feel passionate about.

 

 

Job Summary

This position will be responsible for implementing and maintaining all aspects of regulated scientific software systems.  These systems include Sciex Analyst, Thermo-Fisher Watson, SoftMax Pro, MSD’s Discovery Workbench, and others as needed.  This position will help lead computer system validation efforts and the change control process for the regulated systems.  This position will also be responsible for periodic review of the systems, training of users, and SOP creation/revisions.

 

The following are minimum requirements related to the Scientific System Specialist position.

 

  • Establish/maintain user requirements for software systems and support laboratory information system (LIMS).
  • Plan and prioritize software projects and LIMS updates to meet timelines and business needs.
  • Manage relationships with vendors and outside software development consultants.
  • Validate and maintain systems using GAMP/cGLP guidelines.
  • Maintain validated state of scientific software applications and computer systems (e.g. LIMS, chromatography data system, etc) via the change control process.
  • Work with IT to implement and provide support for backup and disaster recovery methods for all software systems.
  • Manage the deployment, monitoring, maintenance, development, upgrade and support of all software systems including overall database schema, user database access views, accessioning, sample tracking, file transfer, data analysis, instrument interfacing, report generation, report transmission, and archiving.
  • Lead training and/or ensure effective knowledge transfer to those responsible for training.Partner with other technical staff to plan, fix and implement patch releases as required.
  • Manage user expectations through timely communications.
  • Work with software development team to develop and implement software development policies and procedures, including those for architecture, security, disaster recovery standards, purchasing and service provision.
  • Assist in the development and implementation of process and systems improvements.
  • Ensure adherence to pertinent regulatory requirements [ FDA and GAMP guidelines] and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols].
  • Perform all other related duties as assigned.

 

About Discovery
Discovery from Charles River is industry-proven in the successful development of novel therapies, with over 320 patents and 74 preclinical drug candidates delivered to our sponsors in the past 17 years. Backed by more than 650 scientists, our comprehensive, integrated portfolio employs the latest technology and platforms to provide chemistry, biology, and pharmacology services that support clients from the earliest stages of hit identification all the way through to IND. Our client-focused, collaborative approach creates true partnerships that anticipate challenges, overcome obstacles, and move us forward together on the journey of getting new drugs to market.

About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

With over 11,000 employees within 70 facilities in 18 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges.  Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2016, revenue increased by 23.3% to $1.68 billion from $1.36 billion in 2015.

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of ~70% of the drugs approved by the FDA in 2016.

For more information, please visit www.criver.com.

Equal Employment Opportunity
Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet


Nearest Major Market: Worcester

Job Segment: Chemistry, Scientific, Biotech, Pharmaceutical, Science, Engineering, Research