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The Senior Specialist, 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 Senior Specialist will perform root cause analysis, work with stakeholders to identify corrective and preventative actions, and facilitate impact assessments. The Senior Specialist reports to the Senior Manager, Investigations & Compliance within the site Manufacturing Science & Technology department.
Responsibilities include, but are not limited to, the following:
- Conducting and managing the resolution of root cause investigations, including impact assessments, and CAPAs 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.
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 2-4 years' experience in biopharmaceutical operations, or its equivalent is required
- Experience utilizing root cause analysis/OPEX tools and identifying corrective and preventative actions is required
- Experience with Operational Excellence and Lean Manufacturing is a plus
- Experience in cell therapy, biologics, or vaccine manufacturing/support desired
- Experience in cGMP's and multi-national biopharmaceutical/cell therapy regulations desired
- 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
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.
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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 BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
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/ 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.
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