Job Information
Bristol Myers Squibb Senior Specialist - Clinical Site MSAT in Warren, New Jersey
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. Read more: careers.bms.com/working-with-us .
Title: Senior Specialist - Clinical Site MSAT
Location: Warren, NJ
At Bristol Myers Squibb we are reimagining the future of cell therapy . With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.
The Senior Specialist, Clinical Site Manufacturing, Science and Technology (MSAT) is responsible for leading investigations in support of Manufacturing Operations at the Warren, NJ site. This position will be assigned more complex deviation investigations, facilitating teamwork to execute all components within applicable timelines. Deviation investigations will include execution of thorough root cause analyses (RCA) as well as identification of corrective and preventative actions (CAPA) across multiple platforms / programs.
In addition, the role requires consistent compliance within various quality programs / systems, including but not be limited to training, trending, and process / continuous improvements. The position will interface closely with functional teams at the site to drive timeline adherence activity as it pertains to an investigation.
Key Responsibilities:
Under the direction of the Senior Manager, work independently and cross-functionally to perform the following:
Conduct thorough investigations utilizing root cause analysis tools
Lead investigations with the ability to summarize progress to Site Leadership through the collection of triage information and supporting data from both technical and quality teams
Work with functional teams to propose effective CAPAs, develop CAPA plans and assure CAPA effectiveness
Ensure all investigations are completed within system timelines
Notify stakeholders of delays / risks upon discovery
Lead deviation investigation defense during audits and site inspections as deemed necessary by Management
Manage complex issues and solve problems with minimal guidance
Manage teams to support complex investigations
Provide mentorship, guidance, and training to junior members
Continuously living the Patients First mission and fostering a Right First Time mindset
Initiate change control documentation if needed
Qualifications & Experience:
Requires a bachelor's degree in science or engineering ( advanced degree preferred)
Minimum 7 years of relevant work experience, preferably in a health authority regulated environment
Requires demonstrated capability in medium and high-risk deviation reports or equivalent proven experience
Previous experiences working in a biopharmaceutical manufacturing facility and an aseptic environment is preferred (CAR T a plus)
Advanced working experience of deviation investigations utilizing root cause analysis tools
Working experience in the CAPA process and ability to identify and verify effectiveness
Capability to kickoff and lead limited duration investigation teams, to ensure timely completion of more complex investigations
Proven ability to understand, follow, interpret, and apply accurately and completely
Global Regulatory and cGMP requirements
Knowledge of data trending and tracking
Demonstrate advanced problem-solving techniques, technical adeptness, and critical thinking
Advanced technical writing skills, and capability to review investigation reports from more junior team members
Ability to set priorities, manage timelines and effectively update priorities as needed
Ability to work with management to support corporate and departmental goals
Ability to communicate effectively across the site
Ability to utilize electronic quality systems
Direct experience preferred with CAR T or biopharmaceutical manufacturing
Ability to train and mentor junior associates to foster and develop their expertise
Proficiency in MS Word, Outlook, Excel, PowerPoint, Project, and Visio
Critical thinking and decision-making skills
Time management, organizational, and multi-tasking abilities
Ability to solve routine complex problems
Ability to work independently without direct supervision and work within cross-functional teams
Working Conditions:
Physical / Mental Demands
Work is performed in a typical office environment, with standard office equipment that is available and able to be utilized
Work is performed seated but may require standing and walking for approximately 25% of the time
Environmental Conditions
- Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
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 the position. 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.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol-Myers Squibb
Req Number: R1583039
Updated: 2024-07-01 04:14:08.861 UTC
Location: Warren-NJ
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.