Manager, IT/Lab Automation & QA/QC Systems
About Bristol-Myers Squibb:
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.
Description:
- Lead the IT QA/QC Team of support engineers and Business analysts
- Lead the IT/Automation portfolio planning activities and requirement sessions while partnering with internal customers and stakeholders (QA/QC).
- Establish Biologics Laboratory system roadmap and execute on it
- Collaborate with enterprise wide Biologics Lab Teams for system implementation and upgrade of centralized systems
- Maintain and improve System development life cycle, including SOPs, 21CFR part 11 requirements, and software validation.
- Represent IT QA/QC during internal audits and regulatory inspections.
- Tracks project progress to address priorities, meet schedules, maximize productivity, reduce costs, and increase efficiencies.
- Provide updates to management through establishment of project dashboard.
- Invest in the development of current and future employees through assignment of development opportunities, coaching, mentoring, and effective administration of rewards and recognition programs.
Qualification:
- Knowledge of science and Lab systems generally attained through studies resulting in a B.S. Biology and or Science.
- 2 years in a Supervisor/Manager role
- A minimum of 10 years of Laboratory system experience and a proven track record in implementing Laboratory Automation system software.
- A successful candidate will have knowledge of laboratory automation technologies with emphasis on laboratory IT systems (preferably Biovia SmartLab), Empower CDS, NuGenesis SDS. Experience with LIMS, Crystal Reports, and a Document Control platform is preferred.
- Strong knowledge of GMP particularly, preferably as it applies to biologics manufacturing, small molecule manufacturing (drug substance/drug product), and automated systems.
- Strong knowledge of SDLC
- Strong knowledge of Project Management
- Proven ability working in a matrix environment and leading multi-level / cross functional teams to achieve the highest performance in meeting site and departmental objectives.
