Senior Technical Lead, Project Management Packaging & Labeling

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.

Role & Responsibilities:

• Ensures delivery of clinical supplies through effective management of assigned projects.  Manages multiple projects.  Liaise with responsible Trial Supply Managers on aspects of clinical supplies packaging and labelling design and study requirements.  Ensures production schedules meet agreed upon on-time delivery date of finished supplies.  Develops detailed time and event schedules, manages and tracks all activities and milestones related to assigned projects.  Responsible for coordinating availability of all deliverables (e.g. drug product and components, randomization file and label text).

• Oversee the internal packaging and labeling production orders in accordance with the clinical trial design and all relevant regulatory requirements for assigned projects. Ensure the creation and/or release of Bill of Materials and process orders in SAP for assigned projects, including relevant checks on order accuracy.

• Responsible for production order and label order specification review and release and clinical packaging requirements.  Including verification of use date assignments and variable printing information.

• Ensure all required SAP transactions such as goods receipt and goods consumption are executed.  Assures Bill of Material structures are consistent with the requirements of Independent Requirement Order (IRO) and Packaging Specification (PS).  Converts planned orders (print and production) into process orders completing all required user fields and adding long text as required.   Liaises with Quality Assurance to secure release of finished supplies.

• Supports externally managed projects via outsourcing project management. Manages external manufacturing transactions in SAP and sample execution.  Manages and tracks all activities and milestones related to outsourced work and other departmental projects as assigned.   Ensures pricing and terms in label vendor quotation is consistent with MSA.    

• Reviews and approves vendor generated label proofs and other related documents.  Reviews and approves vendor generated production orders and other related documents (i.e. change orders).

• Ensures regulatory and CGMP compliance of activities in assigned areas of responsibility, through monitoring and management of performance and reporting any deviations immediately to the appropriate management and Quality unit.  May enter change controls and deviations into quality management system and conduct investigations as assigned.

• Works cross-functionally with individuals and project teams in various areas.

• Manages and leads internal packaging related quality deviations, including investigations and root cause analysis.

• Identifies opportunities for improving business processes and/or participates on project teams that are focused on continuous improvement.

• Participates in assigned training including CGMP and safety training.

• Authors and reviews procedural documents.

• Oversight of insourcing and alliance internalization activities, includes and n