Manufacturing Training Associate III

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:

The primary purpose of the Manufacturing Training Associate III is to train Manufacturing Associates on all equipment, processes, procedures and practices necessary to contribute to a quality manufacturing environment.

Key Responsibilities


Assists in the development and implementation of a comprehensive, competency-based, high-quality manufacturing training program.

Trains staff on cGMP manufacturing operations per On-the-Job training, standard operating procedures, batch records, and work instructions. Lead Instructor Led Classes independently.

Ensures trainees perform tasks in a manner consistent with safety policies, quality systems, and cGMP requirements.

Train best practices and processes related to a comprehensive on the job training program.

Promotes a high energy, positive, and collaborative culture. Assists in setting-up and maintaining the manufacturing training area(s).

Reviews manufacturing documents for ease of understanding, technical soundness, effective and efficient operations, and cGMP compliance.

Ensures that all training documentation is accurate, complete, and available for review by management or regulatory agencies.

Applies continuous improvement to the training program.

Assess and qualify future Manufacturing trainers.

Collaborates with department managers, supervisors, and trainers on an on-going basis to prioritize training needs and to verify the effectiveness of the training program.

Own department deviations, Corrective Actions/Preventive Actions and perform Change Control Impact Assessments for training.

Participate on department teams.


ey Knowledge, Skills and Abilities


Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.

Exhibits a strong understanding of aseptic technique and cleanroom etiquette.

Demonstrates strong Good Documentation Practices (GDP).

Must have experience performing Environmental Monitoring (EM) and knowledge of EM principles.

Ability to work independently to meet objectives and perform with a high degree of accuracy. Exhibits leadership behaviors including collaborating for results and developing/executing strategy.

Written and verbal communication skills are critical - Must be articulate and able to communicate with and influence employees at multiple levels. Advanced experience with cGMP training programs.

Experience working with Subject Matter Experts and translating content and performance requirements into sound training content.

Ability to coordinate, contribute to and work within a cross-functional team.

Ability to receive and provide feedback in a constructive way.

Ability to maintain collaborative professional relationships with colleagues, peers and all levels of management and with various stakeholder departments.

Ability to thrive in a dynamic and fast-paced environment.

Must possess the ability to take initiative to complete assignments and job responsibilities with minimal supervision.


REQUIRED COMPETENCIES:

Education:


Bachelors in relevant science or engineering discipline, or equivalent in work experience.


Experience


3 years of experience in cGMP manufacturing, experience in cell therapy manufacturing required.


Preferred Experience


Proficient in Microsoft Office programs.


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

Sign Up Now - MiamiCrossing.com