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 Manager, Investigations provides investigation leadership and compliance support to the Devens Cell Therapy Manufacturing Facility. The Devens Cell Therapy Manufacturing Facility is a new facility, and the Manager will perform complex root cause analysis, work with stakeholders to identify corrective and preventative actions, facilitate impact assessments, ensure the Manufacturing Science & Technology team is audit ready, facilitate Annual Product Quality Reviews, and investigate product complaints. The Manager reports to the Senior Manager, Investigations within the site Manufacturing Science & Technology (MSAT) department.
Responsibilities include, but are not limited to, the following:
- Conducting and managing the resolution of complex/multi-functional root cause investigations, including impact assessments, CAPAs, and product complaints as a Lead Investigator
- Collaborating with cross-functional teams as a Lead Investigator including Process Engineering and Support, Engineering and Facilities, Manufacturing Operations, Quality Assurance, Supply Chain, and Quality Control
- Proactively managing the progression of investigations to timely and compliant closure per established KPIs utilizing Project Management tools
- Presentation of investigation findings to key stakeholders and senior management
- Use of Quality Risk Management and Operational Excellence/Six Sigma principles to facilitate risk-based decision-making, drive continuous improvement, and eliminate waste
- Ensuring safe and compliant cGMP operations and maintaining permanent inspection readiness; Actively supporting regulatory inspections
- Staying current with industry trends and BMS standards, and participating in best practice forums consistent with function responsibilities.
- Coaching and mentoring of colleagues on Investigation Program fundamentals and best practices such as GEMBA, Human Error Analysis, DMAIC, and other Root Cause Analysis techniques.
Qualifications and Education Requirements:
- Knowledge of science generally attained through studies resulting in a Bachelor’s degree in science, engineering, biochemistry or related discipline plus a minimum of 5 years’ experience in biopharmaceutical operations, or its equivalent is required
- Experience utilizing root cause analysis tools/OPEX and identifying corrective and preventative actions is required
- Experience with Operational Excellence and/or Lean Principles is a plus
- Experience in cell therapy, biologics, or vaccine manufacturing/support desired
- Proficient in cGMP’s and multi-national biopharmaceutical/cell therapy regulations
- Excellent verbal/written communication skills and ability to influence at all levels
- Ability to think strategically, and to translate strategy into action
- Ability to prioritize and provide clear direction to team members in a highly dynamic environment
- Experience in product complaints and/or APQRs is a plus
WORKING CONDITIONS (US Only):
Position may require working in Clean-Room manufacturing environment approximately 15% of the time. Remainder of work is performed in an office environment.
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. There are other duties and responsibilities that 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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