Senior Specialist, Project Management, Packaging and Labeling

Working at Bristol Myers Squibb

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.

Role and Responsibilities

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.

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.

Experience and Qualifications

Bachelors degree or equivalent in pharmacy, engineering, business or life sciences

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.

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 Overview

New Brunswick - NJ - US : $77,100 - $93,421

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit careers.bms.com / life-at-bms / .

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following : Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility / infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

Uniquely Interesting Work, Life-changing Careers

With 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 a supportive culture, promoting global participation 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 Protocol

BMS has an 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 / 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-1