Senior Manager, Sterile Drug Product, QA Technical OperationsApply
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 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.
Position Summary BMS Cruiserath Biologics is seeking to recruit a Senior Manager, QA Technical Operations for Sterile Drug Product. Reporting to the Associate Director, QA Manufacturing Operations for Sterile Drug Product, the Senior Manager will manage a QA Team supporting the start-up of a commercial drug product manufacturing facility for its biologic's commercial portfolio and clinical pipeline.
Key Responsibilities During Start Up Build a QA Technical Operations team to support start up activities (Design, Build, CQV), GMP operational readiness and Tech Transfer Program.Responsible for hiring, coaching and development of staff.Partnership with CQV team in delivering the GMP scope of work associated with the startup of sterile drug product operations.Quality leadership for Technology Transfer QA approval of SOPs, deviations, CAPAs, change controls, risk assessments, validation documentation and technology transfer documentation for manufacturing operations.Collaboration with functional areas and global network for technical transfer and qualification.Support development and execution of training programs in support of multiproduct manufacturing.Support establishment of Operational Excellence initiatives.Key Responsibilities During Commercial Operations Leadership of QA Technical Operations to support manufacture and release of sterile drug product at Cruiserath.Provide QA technical support for commercial and clinical manufacturing operations.Quality oversight of Product Lifecycle Management Changes, equipment upgrades, automation upgrades, and process improvements.Quality oversight of Major deviations, CAPA's, EV's, Change Controls and Risk Assessments.Participation in internal, corporate, and regulatory inspections.Drives and supports culture of continuous improvement initiatives and safe working practices.Qualifications & Experience The successful candidate must possess:
Bachelor/Masters in Engineering, or Science related discipline with = 10 years in Sterile Drug Product Manufacturing.Deep and demonstrated understanding of the principles of Annex 1 and contamination control strategy.Experience as a team leader with the ability to motivate and develop departmental staff.Proven success working well in a team environment, as well as proven leadership skills.Demonstrated ability to influence work cross functionally in a matrix environment.Why you should apply You will help patients in their fight against serious diseases.You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.You'll get a competitive salary and a great benefits package.#LI-Hybrid If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. 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.
On-site Protocol BMS has a diverse occupancy structure that determines where an employee is required to conduct their work.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.
#J-18808-Ljbffr
