(Lead) Manufacturing Training Associate III
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.
PURPOSE AND SCOPE OF POSITION:
The primary purpose of the (Lead) Manufacturing Training Associate III is to train Manufacturing Associates on all equipment, processes, procedures and practices necessary to contribute to a quality manufacturing environment.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- Bachelors in relevant science or engineering discipline, or equivalent in work experience.
- 2+ years of experience in cGMP manufacturing, experience in cell therapy manufacturing required.
Key Knowledge, Skills and Abilities
- Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
- Exhibits a strong understanding of aseptic technique and cleanroom etiquette.
- Demonstrates strong Good Documentation Practices (GDP).
- Must have experience performing Environmental Monitoring (EM) and knowledge of EM principles.
- Ability to work independently to meet objectives and perform with a high degree of accuracy. Exhibits leadership behaviors including collaborating for results and developing/executing strategy.
- Demonstrates proficiency in written and verbal communication.
- Experience working with Subject Matter Experts and translating content and performance requirements into sound training content.
- Ability to coordinate, contribute to and work within a cross-functional team.
- Ability to receive and provide feedback in a constructive way.
- Ability to maintain collaborative professional relationships with colleagues, peers and all levels of management and with various stakeholder departments.
- Ability to thrive in a dynamic and fast-paced environment.
- Must possess the ability to take initiative to complete assignments and job responsibilities with minimal supervision.
DUTIES AND RESPONSIBILITIES:
- Creates schedules, coordinates materials for on time completion of training program
- Participates in audit-readiness activities such as Gemba walks, storyboard creation, potentially backroom support
- Prepare responses to pre-requests, responding to requests as a SME. Support implementation of requests to findings. Capable of responding and presenting directly to auditor as a SME.
- Assists in the development and implementation of a comprehensive, competency-based, high-quality manufacturing training program.
- Supports and participates in Gemba walks of training activites/materials for proactive gap assessment and deviation prevention.
- Trained and operates in ComplianceWire and Veeva.
- Complete actions association with CAPAs and change controls.
- Executes MFG OJT and ILT training as Qualified Trainer for all MFG Unit Operations.
- SME for 2+ Unit Operation.
- Ensures trainees perform tasks in a manner consistent with safety policies, quality systems, and cGMP requirements.
- Train best practices and processes related to a comprehensive on the job training program.
- Promotes a high energy, positive, and collaborative culture. Assists in setting-up and maintaining the manufacturing training area(s).
- Reviews manufacturing documents for ease of understanding, technical soundness, effective and efficient operations, and cGMP compliance.
- Ensures that all training documentation is accurate, complete, and available for review by management or regulatory agencies.
- Regular interaction with Quality Training department. Develops training programs, executes projects, content creation with support of management.
- Solves problems through cross-departmental collaboration.
- Assess and qualify future Manufacturing trainers.
- Collaborates with department managers, supervisors, and trainers on an on-going basis to prioritize training needs and to verify the effectiveness of the training program.
- Meets timelines without management oversite or intervention.
- Provides updates to management, partner with junior team members on obstacle resolution
WORKING CONDITIONS (US Only):
- Must be able to work in a cleanroom environment that requires gowning.
- Must be able to stand for extended periods of time.
- Work in areas that may have strong magnets.
- Work in areas where handling human blood products (Biosafety Level 2) may be required.
- May work in areas with exposure to vapor phase liquid nitrogen.
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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