Senior Specialist Instructional Designer

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 Sr. Specialist, Instructional Designer is a full-time position located at the S-12 CAR-T Manufacturing Site in the Summit West Campus, NJ. The primary focus for this role is to facilitate the development for instructor-led, on-the-job, and computer-based training courses that support the S12 CAR T facility. This role will provide coaching on training requirements, adult learning principles, curricula design support and alignment to local training processes and with global and / or regulatory requirements.

DUTIES AND RESPONSIBILITIES:

The primary responsibilities of the Sr. Specialist, Instructional Designer are to ensure the effectiveness of training across the S12 organization through the creative and compliant development of training programs that drive and support overall site effectiveness, increase associate skill sets, develop robust training programs that support the resolution of corrective actions and / or preventive actions while ensuring that these programs comply with the internal and regulatory training requirements.

Management Requirements


Support, maintain, encourage, engage and empower a learning culture for trainees and for the Training and Learning Organization

Oversee projects from start to finish

Act as an effective change agent


Technical Requirements


Align, coach, and develop training programs that drive an increase in overall training effectiveness and the empowerment of CAR T personnel

Design and develop training courses using various instructional design and methodologies while incorporating adult learning principles

Contribute to the writing, review, approval and maintenance of metrics, and associated training Standard Operating Procedures (SOPs) or Work Procedures (WP)

Identify, evaluate and implement key performance metrics for training effectiveness and for business expectations regarding training design

Analyze training effectiveness data and lead improvement training and learning initiatives

Create engaging learning activities and compelling course content

Work with Subject Matter Experts to identify target audience’s training needs

Set instructional end goals and create content that matches them

Visualize instructional graphics, the user interface and the finished product

Create supporting materials/media (audio, video, simulations, role plays, games, etc.)

Devise modes of assessments, such as tests, quizzes, to measure the effectiveness of the course

Maintain and control electronic document content and folders as per good documentation requirements

Drive continuous improvement for training programs

Address recurring issues identified throughout S-12 for training

Provide coaching and guidance for training programs that support integration and implementation of new products and/or processes transitioning to the S-12 Manufacturing Plant

Ensure training documentation/files are maintained, with good documentation practices and in compliances with S-12 Quality Systems and retention programs

Work independently and perform with a high degree of accuracy

Partner with other members of Training teams across the organization to build harmony and alignment

Support internal and external Inspections


REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:


Strong experience and an in-depth knowledge of cGMPs, cGTPs, and cGCPs and applicable Health Authority regulations / guidelines and industry best practices for supporting a training program

Instructional design experience incorporating adult learning principles and SMART training objectives

Strong experience and thorough understanding of global regulatory training requirements

Strong experience and an in-depth knowledge of adult learning principles

Capable of leading and working cross-functionally to support the training requirements associated with deviations, change controls, and CAPAs

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

Innovative, proactive, and resourceful; committed to quality and continuous improvement

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

Effective manager of project deliverables

Able to manage multiple priorities

Strong project planning skills

Strong computer skills with MS Office (e.g. Word, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System


Education and Experience:

Bachelor’s degree with 5 years minimum of Training & Learning experience in a cGMP/FDA regulated environment such as manufacturing/QC or QA. (Master’s Degree specializing in Instructional Design is preferred).

OR

High school degree or Associates Degree with 3 years or more CAR- T experience, 5 years minimum of Training & Learning experience, and more than 10 years of experience in a regulated environment

WORKING CONDITIONS (US Only):

This position is in an office and will have time spent working on a computer.

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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