Senior Quality Control Scientist Molecular Trainer

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Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

The Sr. QC Scientist Molecular 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 Training and Learning Organization which is part of the MS&T department.

DUTIES AND RESPONSIBILITIES:

Management Requirements:


Support, maintain, engage, and empower a learning culture for trainees and for the Training and Learning Organization (TLO)

Effectively manages the training schedule

Maintain training laboratories including equipment, training materials


Technical Requirements


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


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 6 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


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 on a daily basis.


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.

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 the resources to pursue their goals, both at work and in their personal lives.

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, disability or protected veteran status.

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