Bristol Myers Squibb Lead Investigator, Manufacturing and Compliance in Cambridge, Massachusetts
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.
External Job Description
The Manager, Senior Lead Investigator provides investigation and compliance support to the Devens Cell Therapy Manufacturing Facility. The Devens Cell Therapy Manufacturing Facility is a new facility, and the Senior Lead Investigator will perform complex root cause analysis, work with stakeholders to identify corrective and preventative actions, ensure the Manufacturing Technology team is audit-ready, facilitate Annual Product Quality Reviews, and investigate product complaints. The Senior Lead Investigator reports to the Senior Manager, Investigations & Compliance within the Manufacturing Technology 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
Collaboration with many different groups/organizations as a Lead Investigator including Process Engineering and Support, Engineering and Facilities, Manufacturing Operations, Quality Assurance, and Quality Control
Proactive management of the progression of investigations and CAPAs to timely and compliant closure per established KPIs
Presentation of investigation findings to key stakeholders and site senior management
Use of Quality Risk Management and Operational Excellence principles to facilitate risk-based decision-making, drive continuous improvement, and eliminate waste
Ensuring safe and compliant cGMP operations and maintains permanent inspection readiness; Active support of 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.
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 leading investigations, performing root cause analysis, and identifying corrective and preventative actions is required
Experience in cell therapy, biologics, or vaccine manufacturing/support
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 with Operational Excellence and Lean Manufacturing is a plus
Experience in product complaints and 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.
Company: Bristol Myers Squibb
Req Number: R1549187
Updated: 2021-12-06 02:41:00.243 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.
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