CAR-T Manufacturing Manager Training and Compliance

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.

PURPOSE AND SCOPE OF POSITION:

Bristol Myers Squibb is seeking a Training and Compliance Manager for Clinical Cell Therapy Manufacturing. The Manager will partner with Manufacturing Leadership and Site Quality to support all aspects of training and compliance for Manufacturing Operations. This person will be a key leader responsible for GMP operations and meeting critical business goals.

DUTIES AND RESPONSIBILITIES:


Establishes and manages the Celgene Warren Manufacturing Training and Compliance team. This includes:

Hiring, mentoring and developing exceptional people

Championing a culture of exceptional teamwork and communication across the organization

Ensuring a culture that embraces the safety of the work environment and the safety of the patients by compliance with company procedures and policies, and cGMP requirements

Develop and deploy manufacturing new hire training program

Revising and developing manufacturing training programs for clinical cell therapy products

Building effective cross-functional relationships

Establishing department goals, tracking and reporting KPIs, and driving continuous improvement efforts

Designing and operating manufacturing systems that are technically sound, promoting effective and efficient operations, and complying with cGMP requirements

Owning and approving deviations and change controls for the manufacturing department and ensure on time closure

Defining and implementing effective CAPAs to improve compliance and manufacturing success

Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients

Reviewing and approving documents, including standard operating procedures, batch records, material specifications, and validation protocols / reports


REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:


Intermediate knowledge of GMP guidance and regulations, particularly those pertaining to GMP training, personnel, and documentation practices.

Drive training program changes that will enhance quality of program and reduce variability of newly trained employees

Advanced skills in using Microsoft Word, PowerPoint and Excel and a high level of organizational and time management skills.

Requires strong interpersonal skills which enable appropriate collaboration with trainees, colleagues, and subject-matter experts.

Continuously evaluate and provide improvements the technical training program

Ability to work in an aseptic environment requiring successful completion of qualification program.

Demonstrated ability to hire top talent

Demonstrated experience building and leading exceptional teams


Education:


Bachelors / Masters in relevant science or engineering discipline


Experience:


8 years of experience in cGMP biologics or cell therapy manufacturing or training, experience in Quality Assurance a plus.

Further preference given to Cell Therapy experience as well.


WORKING CONDITIONS (US Only):

Daily tasks call for extensive walking, standing and occasional lifting of materials. Frequent visual demands require macroscopic and microscopic observations. Employees must work in areas where posted Universal Precautions must be observed and practiced.

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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