CAR-T Manufacturing Training Specialist (R1559496-en-us)
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.
CAR-T Manufacturing Training Specialist
CAR-T Manufacturing Manager, Training and Compliance
PURPOSE AND SCOPE OF POSITION:
The Training Specialist is responsible for the successful implementation of the Cellular Manufacturing Training Program in Warren, NJ. The Training Specialist will be responsible to assess needs, plan, develop, coordinate, monitor and evaluate departmental technical training programs. The Specialist may also perform cleanroom processing duties as a Manufacturing Associate as needed. The Specialist directly contributes to the team performance and team results.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- Intermediate knowledge of GMP guidance and regulations, particularly those pertaining to GMP training, personnel, and documentation practices.
- Drive training program changes that will enhance quality of program and reduce variability of newly trained employees
- Advanced skills in using Microsoft Word, PowerPoint and Excel and a high level of organizational and time management skills.
- Requires strong interpersonal skills which enable appropriate collaboration with trainees, colleagues, and subject-matter experts.
- Continuously evaluate and provide improvements the technical training program
- Ability to work in an aseptic environment requiring successful completion of qualification program.
- Bachelor’s degree or higher in Life Sciences or equivalent in work experience.
- 3-5+ years of work experience in the pharmaceutical industry or relevant work experience required.
DUTIES AND RESPONSIBILITIES:
- Implements training programs that meet regulatory requirements & business needs including:
- Works with the Manager to create a training and development plan to address production demands such that new hires become proficient operators and are contributing to processing stations in a timely fashion.
- Develop training metrics, and KPIs to measure learning effectiveness
- Schedule and conduct the technical training activities such as On- Job training and Instructor Led Training to introduce to aseptic processing and GMP space, and process training.
- Identify learning and training gaps and advise the leadership team on mitigation solutions
- Implement measurement criteria to assess the effectiveness of the training program, and report training compliance metrics to management
- Maintains accurate training documentation and employee record keeping.
- Partnering with the Cross functional subject matter experts and global training function to develop training content and curricula structure.
- Develops / implements new course content as procedures change or as new techniques are introduced.
- Performs competency assessments of operators on an ongoing basis to ensure the knowledge/skills from training are continuously applied.
- Develops course content and procedures including new SOPs, TRNs for manufacturing training programs as necessary.
- Implements the local Manufacturing Operations new hire Training Program including:
- Promotes and exhibit core BMS values in onboarding and training activities.
- Performs administrative tasks such as scheduling training sessions, ordering training supplies, coordinating enrollment, and completing documentation.
- Communicates with different departments to ensure new hires have access to all necessary systems and security.
- Maintains the training status of new hires and communicates progress to Department Management.
- Reports and initiates non-conformances and participate in follow up investigation when necessary.
- Support investigations and CAPA requests associated with the manufacturing process and ensure that the training program remains in alignment.
- Act as Subject Matter Expert during site audits.
- Performs all other duties as required.
WORKING CONDITIONS (US Only):
Ability to perform frequent physical tasks with strength and mobility. Daily tasks call for extensive walking, standing and occasional lifting of heavy materials. Frequent visual demands require macroscopic and microscopic observations.
Employees must work in areas where posted Universal Precautions must be observed and practiced. Associates work daily with potentially harmful and/or hazardous agents including asphyxiating gases (nitrogen), potentially carcinogenic and/or inflammable chemical reagents and sharps.
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.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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