WORKING WITH US

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
Our Analytical Strategy and Operations team creates transformative medicines of tomorrow based on the cutting-edge science of today. Working within Global Product Development and Supply this team uses state-of-the art technologies to develop, enable and execute analytical and CMC strategies that ensure safety, quality and efficacy of life-saving medicines administered to patients in clinical studies. Our team is involved at the earliest stages of Pharmaceutical and Biopharmaceutical product development through the successful commercial launch. As a member of our team, you will get the chance to play a pivotal role to positively impact patients’ lives while developing professionally to achieve your own career goals.

POSITION SUMMARY:

The primary focus of the Laboratory Systems/Scientific Software Liaison role is to lead a team that will provide business ownership of select IT systems throughout their lifecycle. These systems will support both GxP and non-GxP operations across all ASO sites. In addition, this role will be the main conduit for relevant information with Product Development laboratory staff, ASO’s IT Business Partner, system owners & support teams, PDQ/ITQA/ITQS staff, portfolio/finance/PMO teams and management. Finally, this role will be responsible for providing technical leadership to identify new or existing software capabilities that can assist ASO’s continuous improvement activities.

Role & Responsibilities:

• Manage a team of individuals to support the overall position responsibilities.
• Prioritize, manage, and delegate a portfolio of projects simultaneously across the entire team in support of a larger, departmental roadmap. This responsibility includes all three key portfolio management indicators of budget, timeline, and scope.
• Maintain close communication with managers, stakeholders, and team members to keep apprised of system status, project status, impact on laboratory operations, and other relevant items.
• Collaborate with various cross functional colleagues (i.e., scientists, instrument vendors, QA, and IT colleagues) to evaluate opportunities for new digital capabilities in support of continuous improvement activities, setup and qualify new systems or upgrade existing systems for the ASO testing laboratories.
• Provide business ownership of select enterprise/stand alone systems throughout their lifecycle, which typically includes the following steps: 1) Analysis, Design, and System Selection; 2) Validation and Deployment Activities; 3) Operation; 4) Enhancement and Change Control; and 5) Retirement.
• Aggregate/manage information from various sources for owned systems to maintain an overall system status. This information may include roadmap/obsolesce data, risk/issue lists, feature requests.
• Apply FDA CFR 251 Part 11/EU Annex 11 GAMP 5, and other applicable global health authority regulations to the lifecycle of computer systems to ensure they are in a validated state, supporting regulated business processes and computer software assurance.
• Follow SOPs and industry best practices.
• Serve as the ASO Computer System Validation (CSV) subject Matter Expert (SME). Author and/or review validation deliverables including requirement and design specifications, summary reports, pre/post executed test scripts and procedures for supported systems.
• Support operational and compliance initiatives such as periodic reviews of systems, SOP updates, training materials, user requested enhancements, and system audit trail assessments.
• Assist in the preparation of assigned systems for audit readiness. Facilitate audits and participate in the identification or resolution of CAPAs and other QEs.
• Develop standard operating procedures, work instructions, and other quality documents as needed to ensure the integrity of both the laboratory data collected and the systems used to collect the data.
• Stay abreast of current technologies, vendors, and platforms that could potentially benefit laboratory operations.
• Have the ability to define a path forward when there is no defined process.

Experience & Qualifications:

• BS or MS in scientific or IT discipline with minimum 10 years of hands-on laboratory-system experience (LIMS, Chromatography Data systems, or other relevant systems), with at least 3 years in an environment governed by GMP regulations or equivalent experience.
• Minimum 5 years direct experience managing teams, projects, and portfolios.
• Excellent oral and written communication skills in English. In addition, above average competency with the Microsoft Office suite.
• Ability to perform in a highly matrixed organization structure.
• Possess expertise on Good Documentation and Good Testing Practices and solid understanding of cGMPs and Computer System Validations.
• Demonstrated experience installing, configuring, and supporting GMP systems and applications in lab environments. This includes instrument software applications.
• Demonstrated creative and innovative solution with regards to compliance in CSV and identifying areas of potential efficiency/productivity gains.
• Experience with electronic document management systems (e.g., Veeva platform, SharePoint etc.); application development and lifecycle management (e.g., ALM, ValGenesis, etc.)
• Experience with the complete system lifecycle for both regulated and non-regulated systems.
• Experience developing and delivering training for scientific software systems.

LI-Hybrid

GPSProdDev

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

• Manage a team of individuals to support the overall position responsibilities.
• Prioritize, manage, and delegate a portfolio of projects simultaneously across the entire team in support of a larger, departmental roadmap. This responsibility includes all three key portfolio management indicators of budget, timeline, and scope.
• Maintain close communication with managers, stakeholders, and team members to keep apprised of system status, project status, impact on laboratory operations, and other relevant items.
• Collaborate with various cross functional colleagues (i.e., scientists, instrument vendors, QA, and IT colleagues) to evaluate opportunities for new digital capabilities in support of continuous improvement activities, setup and qualify new systems or upgrade existing systems for the ASO testing laboratories.
• Provide business ownership of select enterprise/stand alone systems throughout their lifecycle, which typically includes the following steps: 1) Analysis, Design, and System Selection; 2) Validation and Deployment Activities; 3) Operation; 4) Enhancement and Change Control; and 5) Retirement.
• Aggregate/manage information from various sources for owned systems to maintain an overall system status. This information may include roadmap/obsolesce data, risk/issue lists, feature requests.
• Apply FDA CFR 251 Part 11/EU Annex 11 GAMP 5, and other applicable global health authority regulations to the lifecycle of computer systems to ensure they are in a validated state, supporting regulated business processes and computer software assurance.
• Follow SOPs and industry best practices.
• Serve as the ASO Computer System Validation (CSV) subject Matter Expert (SME). Author and/or review validation deliverables including requirement and design specifications, summary reports, pre/post executed test scripts and procedures for supported systems.
• Support operational and compliance initiatives such as periodic reviews of systems, SOP updates, training materials, user requested enhancements, and system audit trail assessments.
• Assist in the preparation of assigned systems for audit readiness. Facilitate audits and participate in the identification or resolution of CAPAs and other QEs.
• Develop standard operating procedures, work instructions, and other quality documents as needed to ensure the integrity of both the laboratory data collected and the systems used to collect the data.
• Stay abreast of current technologies, vendors, and platforms that could potentially benefit laboratory operations.
• Have the ability to define a path forward when there is no defined process