Senior Technical Lead, Project Management Packaging & Labeling
Working with UsChallenging. 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 not limited to management of packaging readiness meetings, tiger team and CMC level representation.
CSO representation and alignment at the CMC meetings to ensure alignment on manufacturing and supply strategies.
Experience & Qualifications:
Bachelor's degree in life sciences or an equivalent combination of experience and/or training may substitute.
7-9 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.
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.Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolBMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.Company: Bristol-Myers SquibbReq Number: R1586754Updated: 2024-10-27 02:16:25.109 UTCLocation: New Brunswick-NJBristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.