Director, Cell Therapy Facilities Quality
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The Cell Therapy Facility Quality Project Director is responsible for supporting and providing quality oversight of cell therapy facility capital projects, to enable on-time and on-budget realization of those projects, while meeting all applicable GMP regulations, guidance, and industry best practices. The role will contribute to quality aspects of world-class project execution of all project phases, from feasibility studies, project initiation, and planning phases through facility start-up and/or project completion. The role will also provide guidance to assure projects comply with existing or new BMS standards
DUTIES AND RESPONSIBILITIES:
- Quality support of Cell Therapy facility projects including but not limited to facility feasibility, selection, design, build, commissioning, and start-up.
- Provide technical and project support with a Quality team comprised of Quality Subject Matter Expert (SME) leads from Quality Assurance, Quality Control, Quality Systems, Compliance, validation, etc.
- Engage appropriate Quality SME leads at appropriate intervals in the projects to ensure robust Quality oversight.
- Ensure applicable global GMP regulation requirements, guidance, and industry best practices are incorporated into all phases of the projects, as well as compliance with any internal procedures and standards.
- Lead and champion proactive identification and resolution of technical and compliance issues/gaps.
- Provide support with the Quality SME team on the first technology transfer of clinical and/or commercial products into the facilities. For a commercial product, ensure Quality oversight of the Process Performance Qualification (PPQ) prior to full commercial operations.
- Requires a minimum of 50% travel to lead project execution.
- Support other Quality projects as defined by the manager
- Knowledge of cGMP regulations and standards of relevant health authorities (e.g., FDA, EMA, PMDA) and their guidelines applicable to biologics and cell therapy/ATMP Regulations.
- Familiar with industry and corporate standards facilities, equipment, and instruments, including automation requirements/guidance (GAMP 5, ISA Standards, etc.). Capability to relate and assimilate those standards to capital projects for cell therapy facilities, manufacturing and QC equipment, and instrumentation, and GMP software and electronic systems (local and enterprise)
- Proven capability for leading or fulfilling a significant role on cross-functional project teams, with a demonstrated track record of achieving results (e.g., driving team performance, effectively conceptualizing the impact of Quality initiatives, influencing, decision-making, building relationships, innovative thinking)
- Capability for interpreting complex results and situations with a high degree of independence, and effectively articulating recommendations and surrounding communications to management, stakeholders, and other team members with clarity, brevity, and accuracy.
- Able to recognize risk to organization or project objectives and provide leadership to the development of contingency plans, including cross-functional negotiation of solutions. Possesses capability for effectively managing internal and cross-functional conflicts and disagreements, but able to stand alone on issues
- Strong motivating team player, drives results, excellent communication skills.
- Capable of managing diverse stakeholders in multicultural environments.
EDUCATION AND EXPERIENCE (As Applicable):
- Bachelor of Science degree in Biological Sciences, Biomedical/Chemical Engineering, or Engineering; equivalent experience and/or education in other disciplines may also be considered.
- Minimally 10+ years of biotech, cell therapy, or pharmaceutical industry experience in quality, process development, process scale-up/manufacturing, technology transfer, and process validation.
- Minimum of 10+ years working in a commercial-scale Quality, Engineering, Manufacturing role (or combination thereof) within a commercial biopharmaceutical, cellular therapy, or gene therapy organization.
WORKING CONDITIONS: (US Only):
- Equipment Usage During Work Period: Computer 70%; Phone and Electronic Devices 30%
- Sitting at a computer for an extended period
- Regular sitting, standing, talking, using hands & fingers to operate a computer and telephone keyboard.
- Requirement to work in a conference room/meeting environment for moderate periods.
- Occasional periods in buildings under construction, labs, or production areas, requiring some level of gowning/PPE.
- Moderate noise, i.e., business office with computers, phone, and printers
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Some other duties and responsibilities are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
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