Sr. QC Scientist, Analytical Trainer
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 Sr. QC Scientist Analytical Trainer is responsible for managing and administrating the training program to support the bioanalytical testing CAR-T manufacturing at the Summit NJ site. This includes, but is not limited to, assisting with the development and maintenance of training materials, delivering instructor-led, on-the-job, and virtual training. This position works with SMEs to schedule training, learn new equipment or product launches, and assists with related projects in support maintaining training proficiency. This position is a member of the QC-Training .
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
Advanced knowledge of cGMP training requirements
• Advanced Knowledge of QC Laboratory functionality
• Advanced hands on knowledge of Bioanalytical Techniques, Aseptic techniques including but not limited to FACS, ELISA, qPCR, and other Cell Biology and Molecular Biology techniques.
• Knowledge of cGMP Regulations and how they apply to QC laboratory activities
• Experience in performing training in a cGMP regulated environment
• Advanced written and verbal communication and presentation skills
• Experience with cGMP Learning Management Systems and other enterprise applications
• Strong collaboration and organization skills • Advanced ability to teach and coach
• Ability to work collaboratively on cross-functional teams • Proficiency in Microsoft Office applications • Ability to solve complex problems
• Ability to provide on-call support in case of emergency issues
• Ability to work as a detailed oriented team player with effective planning, organization and execution skills
Education and Experience:
• Bachelor’s Degree, preferable in Cell Biology and Molecular Biology, or equivalent relevant experience • Advanced Degree preferred
• Minimum 5 years of experience within the biologic, pharmaceutical or medical device industry with responsibilities for developing or delivering training to colleagues and/or managing a training program
• 1-3 years of experience as a trainer ideal
• Experience and understanding of biological manufacturing processes and aseptic techniques a plus • An equivalent combination of education and experience may substitute
DUTIES AND RESPONSIBILITIES:
• Support, maintain, engage, and empower a learning culture for trainees
• Effectively manages the training schedule • Maintain training laboratories including equipment, training materials
• Review all data in accordance with applicable procedures and cGMP requirements
• Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner • Become a Qualified Trainer
• Deliver Training effectively as per the approved training materials and methods or governing procedures
• Document training as per approved training materials
• Assist with the development of curricula and training materials
• Identify opportunities to improve training operations or laboratory process or setup
• Maintain control of training documents and assist with the proper filing within the training and learning team
• Continue to grow in cell biology and molecular biology techniques • Cross train on other components, tasks, of the QC laboratory to become a trainer for those areas as well
• Work with training department and SMEs to ensure that QC lab personnel are appropriately trained to perform relevant tasks
• Ensure critical procedures have appropriate mechanisms to demonstrate comprehension and understanding
• Implement best training practices as appropriate • Establish Training laboratory facility to accommodate hands on training across multiple QC methods • Maintain training laboratories including equipment, training materials and training schedules
• Manage and facilitate instructor lead trainings, virtual trainings, and on the job trainings
• Support molecular based technique training and other departmental training as appropriate
• Maintain training metrics • Perform approvals for relevant training activities • Author and review training documents as required • Participate in technical transfers or new projects (e.g. new equipment launces, etc.) to become the qualified trainer
• Train junior trainers on the process and equipment associated with the QC Laboratory
• Support document revision, CAPA and investigation/ change control tasks from a training perspective • Performs other tasks as assigned
WORKING CONDITIONS (US Only):
• The incumbent will be working in a laboratory setting 4 -10 hours per day.
• The incumbent will be working around biohazardous materials, including chemical agents, 4 - 10 hours per day.
• The incumbent should be able to distinguish colors and possess correctable vision to 20/20, annual eye exam is required.
• The incumbent must analyze numerical values daily. 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 email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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