Senior Specialist, Project Management - Packaging and Labeling

Bristol Myers Squibb • New Brunswick, NJ

13h • Hybrid

About The Position

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 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. 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.

Requirements

• Bachelor’s degree or equivalent in pharmacy, engineering, business or life sciences and 3 - 5 years relevant experience in the pharmaceutical industry or related healthcare environment.
• Demonstrates ability to plan, manage and execute multiple projects and to deliver against critical timelines in a fast-paced, rapidly changing environment.
• Strong project management skills.
• Possesses solid oral and written communication skills.
• Good decision making and organizational skills.
• Demonstrates ability to effectively communicate ideas and to influence others to achieve results.
• Ability to understand and apply regulatory and CGMP principles.
• Knowledge of ERP/MRP systems and supply chain principles.

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.
• Executes TECO transaction on completed process orders.
• Compiles supporting documentation and delivers a body of evidence (batch records) that supports the release of finished supplies for clinical use.
• Liaises with Quality Assurance to secure release of finished supplies.
• Supports externally managed projects via outsourcing project management; generates and approves project specifications for label print and production.
• 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.
• Circulates purchase justification memos and issues purchase orders in accordance with company policy.
• 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.
• Manage external packaging and labeling activities
• Responsible for improving business processes and /or participate in project teams or initiatives that are focused on continuous improvements.
• Participates in assigned training including CGMP and safety training.
• Authors and reviews procedural documents.
• Manages and leads internal packaging related quality deviations, including investigations and root cause analysis.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level