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in New Brunswick, NJ

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Hours Full-time, Part-time
Location New Brunswick, New Jersey

About this job

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 . Join us as a Senior Packaging Manager to contribute to the success of our commercial packaging operations. The Senior Packaging Manager will oversee commercial packaging operations for BMS products at external contract manufacturing sites (CMO). This position plays a key role in product packaging as a member of cross-functional development programs, supporting projects from concept through commercialization. Provide Packaging technical support to the External Manufacturing Organization (ExM) and CMOs Ensure the transfer of robust Primary and Secondary Drug Product Packaging processes to Contract Manufacturing Organizations (CMO) Assess and maintain robust packaging process performance at CMOs for the primary and secondary packaging of BMS products Actively works to continuously reduce supply risks associated with packaging operations and processes Maintains current knowledge of primary and secondary packaging types/technology, packaging processes, packaging equipment and serialization to support the successful operation of the ExM business unit Responsibilities: Support the CMO selection process – a compilation of technical packages, due diligence, and completing the scoring. Leads packaging robustness assessment and improvement initiatives Accountable for/Leading technology transfer packaging projects, ensuring robust technical transfer within budget constraints, and completing associated regulatory filings Support operational management of packaging CMOs as per the Supplier Relationship Management governance model Provide ongoing technical support to ExM / CMO to ensure compliance and security of supply – metrics review, deviation closure, CAPA effectiveness, change control review, APQR review, and process/yield improvement. Identify and implement OPEX initiatives as necessary Leads process investigations when required, using structured root cause analysis tools Represents Manufacturing, Science & Technology on project teams and works closely with Supply Relationship Manager and other project team members Product robustness - technical lead for creating process robustness monitoring plan and process control strategy and providing technical oversight of sites to ensure continuous process monitoring for all products in scope Supervise MS&T specialist, contractor, or intern when required. Provide technical support for packaging to CMOs and External Manufacturing Organization (ExM) Ensure successful transfer of primary and secondary drug product packaging processes to CMOs Maintain robust and efficient packaging process performance at CMOs for BMS products Reduce supply risks associated with packaging operations and processes Stay updated on packaging types/technology, equipment, and serialization Knowledge/Skills: Ability to interact at all levels of the organization with proven influencing ability e.g. Regulatory, CMO to achieve goals Strong negotiation capability and ability to manage complex stakeholder networks Ability to understand the business implications of technical decisions Knowledge of Characterization/Analytical Techniques for measuring critical quality attributes of packaging materials In-depth knowledge of the regulatory standards and compliance expectations for packaging processes Knowledge of serialization requirements and serialization technology Proficient in the technical transfer of packaging processes to CMOs within budget and according to project timeline Demonstrated ability to manage one or more tech transfer projects with minimal supervision Excellent verbal and written communication and presentation skills, including concisely writing complex study plans and scientific reports and informing diverse stakeholder groups about the critical issues related to packaging processes when required Ability to work independently and as part of a team and to drive issues to resolution Basic Qualifications: Bachelor’s degree in science or a related field Minimum 5 years of experience in pharmaceutical packaging technology, technology transfer, process development, and packaging support/activities Demonstratable knowledge of primary packaging processes and process equipment for OSD blister packaging, bottles, and sachets; sterile and nonsterile (bottle filling, vial filling) Experienced with the use of statistical software to analyze process-related data to determine process capability or for troubleshooting purposes Experience using FMEA/Risk Assessments for optimizing primary and secondary packaging processes Preferred Qualifications Master’s degree or above is beneficial 7 years of experience in pharmaceutical packaging technology, technology transfer, process development, and packaging support/activities Working Conditions No hazardous or disagreeable conditions. Approximately 20% travel annually. 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 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 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 Protocol Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. 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. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Company: Bristol-Myers Squibb Updated: 2024-02-19 01:20:00.013 UTC Bristol 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. #J-18808-Ljbffr