Senior Quality Control Scientist Micro Trainer

Profile

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 QC Scientist Micro Trainer is responsible for managing and administering the training program for Microbiology and Environmental Monitoring CAR-T QC laboratories. This includes, but is not limited to, establishing and maintaining curriculum for lab personnel, assisting with on the hands on, and working with SMEs to schedule training. Additionally, the QC Senior Scientist Training will manage the microbiology and aseptic qualification training laboratories and assist with related projects in support of maintaining training proficiency. This position will work closely with the site’s training and development team.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Knowledge of cGMP/Pharmaceutical regulations

Advanced knowledge of QC Microbiology Laboratory Functionality

Advanced hands on knowledge of aseptic techniques

Advanced hands-on knowledge of various microbiology and environmental monitoring techniques including but not limited to Endotoxin testing, Sterility testing, Gram Stain, Growth Promotion, and qPCR

Capable of writing technically

Capable of leading and working cross-functionally

Proven experience working as a detailed oriented team player with effective planning, organization and execution skills

Ability to work effectively at a fast pace with cross functional departments to finalize time-sensitive deliverables

Has a customer service mindset to ensure all stakeholder needs are met

Proficient written and verbal communication skills

Proficient presentation delivery skills

Technical writing capability

Ability to solve routine and complex problems

Ability to provide on-call support in case of emergent issues

Education and Experience:

Bachelor’s degree preferred or Associate degree / high school diploma with additional work experience described below.

Bachelor’s degree with 6 years relevant work experience required, preferably in a regulated pharmaceutical manufacturing environment.

Associate degree or high school diploma with 8 years relevant work experience required, preferably in a regulated environment.

An equivalent combination of education, experience and training may substitute.

DUTIES AND RESPONSIBILITIES:

The primary responsibilities for the Sr. QC Scientist Micro Trainer are to ensure the effective qualification of trainees for EM and Micro specific laboratory techniques.

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

Support microbiology and environmental monitoring techniques training and other departmental training as appropriate

Develop and deliver training presentations on pertinent topics to large groups of personnel on an as needed basis, including annual refresher training, remedial training and on as a needed basis to support QC

Maintain training metrics

Perform approvals for relevant training activities

Author and review training documents as required

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 environmental and micro biology techniques

Establish Training laboratory facility to accommodate hands on training across multiple microbiology and environmental monitoring QC methods

Manage and facilitate instructor lead trainings and on the job trainings

Cross train on other components, tasks, of the QC laboratory to become a trainer for those areas as well

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.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com