Bristol Myers Squibb
Senior Specialist, Project Management, Packaging and Labeling
Bristol Myers Squibb, New Brunswick, New Jersey, us, 08933
Senior Specialist, Project Management, Packaging and Labeling
Overview Role focusing on delivering clinical supplies packaging and labeling for trials. Supports external and internal packaging and labeling activities, ensures regulatory compliance, and drives continuous process improvement within Global Product Development and Supply. Responsibilities
Ensures delivery of clinical supplies through effective management of assigned projects. Manages multiple projects and liaises with responsible Trial Supply Managers on aspects of clinical supplies packaging and labeling design and study requirements. Ensures production schedules meet on-time delivery dates of finished supplies. Develops detailed time and event schedules, manages and tracks activities and milestones, and coordinates availability of all deliverables (e.g., drug product and components, randomization file and label text). Oversee internal packaging and labeling production orders in accordance with the clinical trial design and regulatory requirements for assigned projects. Ensure creation and/or release of Bill of Materials and process orders in SAP for assigned projects, including checks on order accuracy. Review and release production orders and label orders and ensure clinical packaging requirements are met, including verification of use date assignments and variable printing information. Ensure required SAP transactions (goods receipt, goods consumption) are executed. Maintain Bill of Materials structures consistent with Independent Requirement Order (IRO) and Packaging Specification (PS). Convert planned orders into process orders, complete required user fields, add long text as needed, and execute TECO on completed orders. Compile supporting documentation and deliver batch records that support release of finished supplies for clinical use; liaise with Quality Assurance to secure release. Support externally managed projects via outsourcing project management; generate and approve project specifications for label print and production. Manage external manufacturing transactions in SAP and oversee sample execution; track activities and milestones related to outsourced work and other departmental projects. Ensure pricing and terms in label vendor quotations align with the Master Service Agreement; circulate purchase Justifications and issue purchase orders per policy. Review and approve vendor-generated label proofs, production orders, and related documents (e.g., change orders). Ensure regulatory and CGMP compliance within assigned areas, monitor performance, and report deviations to management and Quality. Enter change controls and deviations into the quality management system and conduct investigations as assigned. Collaborate cross-functionally with project teams in various areas; manage external packaging and labeling activities. Strive to improve business processes and participate in project teams or initiatives focused on continuous improvements. Participate in assigned training including CGMP and safety training; authors and reviews procedural documents. Manage and lead internal packaging-related quality deviations, including investigations and root cause analysis. Experience and Qualifications
Bachelors degree or equivalent in pharmacy, engineering, business or life sciences. 3–5 years of 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 environment. Strong project management skills and solid oral and written communication skills. Good decision making and organizational skills; ability to influence others and communicate ideas effectively. Ability to understand and apply regulatory and CGMP principles. Knowledge of ERP/MRP systems and supply chain principles. 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. Compensation and Benefits
The starting compensation range for this role is listed for a full-time employee. Additional incentive cash and stock opportunities may be available. Benefits include medical, dental, vision, retirement, and work-life programs; details vary by location. Uniquely Interesting Work, Life-changing Careers: Transforming patients\' lives through science, empowering employees to contribute their talents in a collaborative culture with shared values. On-site and work location guidance varies by role and is defined by the company; accommodations for accessibility are provided upon request during recruitment. EEO statement and further details are available on the company careers site. All data processed in relation to role applications will be handled in accordance with applicable data privacy policies and regulations.
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Overview Role focusing on delivering clinical supplies packaging and labeling for trials. Supports external and internal packaging and labeling activities, ensures regulatory compliance, and drives continuous process improvement within Global Product Development and Supply. Responsibilities
Ensures delivery of clinical supplies through effective management of assigned projects. Manages multiple projects and liaises with responsible Trial Supply Managers on aspects of clinical supplies packaging and labeling design and study requirements. Ensures production schedules meet on-time delivery dates of finished supplies. Develops detailed time and event schedules, manages and tracks activities and milestones, and coordinates availability of all deliverables (e.g., drug product and components, randomization file and label text). Oversee internal packaging and labeling production orders in accordance with the clinical trial design and regulatory requirements for assigned projects. Ensure creation and/or release of Bill of Materials and process orders in SAP for assigned projects, including checks on order accuracy. Review and release production orders and label orders and ensure clinical packaging requirements are met, including verification of use date assignments and variable printing information. Ensure required SAP transactions (goods receipt, goods consumption) are executed. Maintain Bill of Materials structures consistent with Independent Requirement Order (IRO) and Packaging Specification (PS). Convert planned orders into process orders, complete required user fields, add long text as needed, and execute TECO on completed orders. Compile supporting documentation and deliver batch records that support release of finished supplies for clinical use; liaise with Quality Assurance to secure release. Support externally managed projects via outsourcing project management; generate and approve project specifications for label print and production. Manage external manufacturing transactions in SAP and oversee sample execution; track activities and milestones related to outsourced work and other departmental projects. Ensure pricing and terms in label vendor quotations align with the Master Service Agreement; circulate purchase Justifications and issue purchase orders per policy. Review and approve vendor-generated label proofs, production orders, and related documents (e.g., change orders). Ensure regulatory and CGMP compliance within assigned areas, monitor performance, and report deviations to management and Quality. Enter change controls and deviations into the quality management system and conduct investigations as assigned. Collaborate cross-functionally with project teams in various areas; manage external packaging and labeling activities. Strive to improve business processes and participate in project teams or initiatives focused on continuous improvements. Participate in assigned training including CGMP and safety training; authors and reviews procedural documents. Manage and lead internal packaging-related quality deviations, including investigations and root cause analysis. Experience and Qualifications
Bachelors degree or equivalent in pharmacy, engineering, business or life sciences. 3–5 years of 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 environment. Strong project management skills and solid oral and written communication skills. Good decision making and organizational skills; ability to influence others and communicate ideas effectively. Ability to understand and apply regulatory and CGMP principles. Knowledge of ERP/MRP systems and supply chain principles. 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. Compensation and Benefits
The starting compensation range for this role is listed for a full-time employee. Additional incentive cash and stock opportunities may be available. Benefits include medical, dental, vision, retirement, and work-life programs; details vary by location. Uniquely Interesting Work, Life-changing Careers: Transforming patients\' lives through science, empowering employees to contribute their talents in a collaborative culture with shared values. On-site and work location guidance varies by role and is defined by the company; accommodations for accessibility are provided upon request during recruitment. EEO statement and further details are available on the company careers site. All data processed in relation to role applications will be handled in accordance with applicable data privacy policies and regulations.
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