Senior Manager, Clinical Supply Operations Automation

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 rich in diversity. 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 Clinical Supply Operations is responsible for the supply of drug product administered to patients in clinical studies worldwide. In Global Product Development and Supply the team works closely with our partners to deliver quality products safely, efficiently and on time while operationalizing the innovative technologies that will deliver the transformative medicines of tomorrow. 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:

This position implements and supports all automation activities as related to the business strategies in Clinical Supply Operations (CSO) including Delta V electronic batch record administration, integration with corporate enterprise networks, within the Oral Solid Dosage and Parenterals manufacturing areas, as well as overall manufacturing process equipment and recipe automation support and improvements.

Role & Responsibilities:

• Manages the life cycle of an Emerson DeltaV Distributed Control System responsible for CSO electronic batch records.  Delta V administrator responsibilities include Delta V system configuration (batch and recipe), new process field equipment integration, SQL applications/interfacing both inside/outside Delta V, Visual Basic configuration, SAP functionality, system security, and Enterprise interfaces. 
• Management of automated systems future growth including upgrades, resource allocation, cost vs. benefit analysis, qualification, and GMP readiness. Ensures that automation systems are designed, built and maintained in compliance with regulatory requirements and current technology.
• Responsible for day-to-day DeltaV system management and recipe/batch support/troubleshooting.  As required, provides twenty-four hour on-call troubleshooting coverage for DeltaV recipe/batch support.
• Prepares and executes qualification and system life-cycle protocols, IOQs, SOPs and cGMP training for automated systems and equipment.  Specifically in areas of electronic batch recipe review and approval as related to DeltaV Operations as well as new equipment integration into manufacturing.
• Provides equipment PLC (Rockwell and Siemens) support for the implementation of upgrades and system troubleshooting for CSO manufacturing and processes.  Manages all PLC configuration archiving and backups for area.
• Understands multiple BUS Technology Protocols and Interfacing I/O processing as well as cGMP’s as it relates to data integrity.
• Understands that the work environment may require the use of Powered Air Purifying Respirator (PAPR).
• Understands the business risks and organizational dynamics involved with implementing advanced automation strategies. Harmonizes consistent cross-departmental automation approaches to achieve desired results.
• ·Establishes and maintains both horizontal and vertical working relationships to influence outcomes and maximize effective communication, ensuring a timely and appropriate response to business issues.
• Manages and develops people through coaching and leadership development. Directs internal and external resources to achieve specific results by fostering effective team skills. Builds and motivates automation project teams to provide innovative approaches while achieving business results.
• Manages and prioritizes automation activities around process area schedules to meet the manufacturing automation requirements.
• Stays proactively abreast of changing automation technologies and regulations to ensure that Delta V manufacturing operations remains compliant and current.  Contributes