Specialist, Manufacturing Technical Development

About the role

Bristol Myers Squibb is seeking a Specialist, Manufacturing Technical Development to join our team. This role is responsible for implementing and administering training programs that meet regulatory requirements and business needs.

Responsibilities

• Works with the Manager to create a training and development plan to address production demands such that new hires become proficient operators and are contributing to processing stations in a timely fashion.
• Conducts ILT and OJT sessions to ensure cleanroom operators are proficient.
• Provides feedback to trainees to ensure all skills / knowledge have been acquired and communicates any skill/knowledge gaps that require additional training.
• Collaborates with the Manager to ensure training is compliant and effective.
• Maintains accurate training documentation and employee record keeping.
• Develops course content and procedures including new SOPs, TRNs for manufacturing training programs as necessary.
• Implements the local Manufacturing Operations new hire Training Program.
• Executes/Implements batch records in ISO 7 & 8 clean room environments.
• Completes and maintains aseptic processing and sterile gowning qualifications.
• Communicates with Quality Control to ensure proper handoff of process samples.
• Interacts with Supply Chain, Facilities, and Development as needed to ensure smooth operation, and escalates any issues involving safety or product quality up the appropriate channels.
• Reports and initiates non-conformances and participates in follow-up investigations when necessary.

Qualifications

• A high level of understanding of cell therapy processes, controls, and GMP requirements.
• Intermediate skills in design, development, and implementation of training.
• Advanced skills in using Microsoft Word, PowerPoint, and Excel.
• High level of organizational and time management skills.
• Ability to communicate information clearly to facilitate effective learning.

Skills

• Strong interpersonal skills.
• Ability to work in an aseptic environment.

Benefits

Our benefits include: Health Coverage, wellbeing support, financial well-being and protection, and work-life benefits. Additional incentive cash and stock opportunities may be available.

Pay

$38.12 - $46.20 per hour

Schedule

Monday through Friday, 3:00pm to 11:30pm

Shift Differential

10%

Reporting Relationship

Manufacturing Technical Development Manager