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 the successful implementation of the site Manufacturing Training Program.

Responsibilities

• Implements training programs that meet regulatory requirements & business needs including:
• 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.
• Works with the Manager on an on-going basis to implement training goals and meet KPI’s.
• 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.
• Solicits feedback from trainees to ensure the appropriateness of course content, and for continuous improvement opportunities.
• Collaborates with the Manager to ensure training is compliant and effective.
• Maintains accurate training documentation and employee record keeping.
• Seeks feedback from Department Management to assess training needs and to identify areas for continuous improvement.
• Develops course content and procedures including new SOPs, TRNs for manufacturing training programs as necessary.
• Collaborates with the Manager and Quality to identify trends which may require amendment to training programs.
• Develops / implements new course content as procedures change or as new techniques are introduced.
• Performs competency assessments of operators on an ongoing basis to ensure the knowledge/skills from training are continuously applied.
• Implements the local Manufacturing Operations new hire Training Program including:
• Promotes and exhibit core BMS values in onboarding and training activities.
• Develops an on-the-job training schedule that accommodates individuals of various levels of experience and follows all regulatory and technical requirements.
• Performs administrative tasks such as scheduling training sessions, ordering training supplies, coordinating enrollment, and completing documentation.
• Conducts ITL/OJT structured trainings for new hires to introduce to aseptic processing and GMP space, and process training.
• Communicates with different departments to ensure new hires have access to all necessary systems and security.
• Maintains the training status of new hires and communicates progress to Department Management.
• Maintain the Training Laboratory and equipment for cleanliness and compliance.
• Complete room activity, maintenance, cleaning, and equipment usage logs (as required).
• Run daily calibration checks on equipment where appropriate and escalate deviations.
• Perform routine cleaning of laboratory areas and equipment.
• Ensure sufficient laboratory supplies for daily training activities.
• Manufacture clinical grade cellular therapeutic products to supply the Clinical Program (as needed):
• Execute/Implement batch records in ISO 7 & 8 clean room environments.
• Observe, practice, and promote all aspects of the GMP & GDP requirements.
• Complete and maintain aseptic processing and sterile gowning qualifications.
• Communicate with Quality Control to ensure proper handoff of process samples.
• Interact with Supply Chain, Facilities, and Development as needed to ensure smooth operation, and escalate any issues involving safety or product quality up the appropriate channels.
• Collaborate with members of internal teams to drive process improvements and assist with implementation of changes by utilizing quality systems.
• Reports and initiates non-conformances and participate in follow up investigation when necessary.

Qualifications

• Requires 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.
• Requires a high level of organizational and time management skills.
• Ability to communicate information clearly to facilitate effective learning.
• This position requires speaking in classroom settings.
• Ability to work in an aseptic environment requiring successful completion of a qualification program.
• B.S. in Biology, Biochemical, Chemical, or Biomedical Engineering or related discipline with 4-5+ years of relevant experience in a clinical laboratory or blood/cell culture processing environment.

Skills

• 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.
• Organizational and time management skills.
• Clear communication skills.
• Experience in aseptic environments.
• Bachelor's degree in Biology, Biochemical, Chemical, or Biomedical Engineering or related discipline.
• Relevant experience in a clinical laboratory or blood/cell culture processing environment.

Benefits

Our benefits package includes:

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life Benefits Include: Paid Time Off, Unpaid Time Off, and Leaves of Absence.