Specialist, Training and Development

About the role

Specialist, Manufacturing Technical Development is responsible for the successful implementation of the site Manufacturing Training Program. The Specialist develops and administers training solutions that adhere to the Site Training Program. This position trains other staff members, as well as assesses their ability to perform tasks proficiently. The Specialist may also perform cleanroom processing duties as a Manufacturing Associate as needed.

Responsibilities

• Implements training programs that meet regulatory requirements and business needs, including:
  • Works with the Manager to create a training and development plan to address production demands, ensuring new hires become proficient operators and contribute to processing stations in a timely fashion.
  • Works with the Manager on an ongoing basis to implement training goals and meet KPIs.
  • Conducts Instructor-Led Training (ILT) and On-the-Job Training (OJT) sessions to ensure cleanroom operators are proficient.
  • Provides feedback to trainees to ensure all skills and knowledge have been acquired and communicates any gaps requiring additional training.
  • Solicits feedback from trainees to ensure the appropriateness of course content and identify opportunities for continuous improvement.
• 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 identify areas for continuous improvement.
• Develops course content and procedures, including new Standard Operating Procedures (SOPs) and Training Records (TRNs) for manufacturing training programs as necessary.
• Collaborates with the Manager and Quality to identify trends that may require amendments to training programs.
• Develops and implements new course content as procedures change or new techniques are introduced.
• Performs competency assessments of operators on an ongoing basis to ensure knowledge and skills from training are continuously applied.
• Implements the local Manufacturing Operations new hire Training Program, including:
  • Promotes and exhibits core BMS values in onboarding and training activities.
  • Develops an on-the-job training schedule accommodating individuals of various experience levels while following all regulatory and technical requirements.
  • Performs administrative tasks such as scheduling training sessions, ordering training supplies, coordinating enrollment, and completing documentation.
  • Conducts structured ILT/OJT for new hires to introduce aseptic processing, 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.
• Maintains the Training Laboratory and equipment for cleanliness and compliance, including:
  • Completes room activity, maintenance, cleaning, and equipment usage logs as required.
  • Runs daily calibration checks on equipment and escalates deviations.
  • Performs routine cleaning of laboratory areas and equipment.
  • Ensures sufficient laboratory supplies for daily training activities.
• Manufactures clinical-grade cellular therapeutic products to supply the Clinical Program (as needed), including:
  • Executes and implements batch records in ISO 7 and 8 cleanroom environments.
  • Observes, practices, and promotes all aspects of GMP and GDP requirements.
  • 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 to ensure smooth operation and escalates issues involving safety or product quality.
• Collaborates with internal teams to drive process improvements and assist with implementation of changes using quality systems.
• Reports and initiates non-conformances and participates in follow-up investigations when necessary.
• Performs all other duties as required.

Qualifications

• Requires a high level of understanding of cell therapy processes, controls, and GMP requirements.
• Intermediate skills in the 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, including speaking in classroom settings.
• Requires strong interpersonal skills for collaboration with trainees, colleagues, and subject-matter experts.
• 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.

Pay

Summit West, NJ, US: $38.12 - $46.20 per hour for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate accounts for required skills, job location, work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Benefits

• 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:
  • Paid Time Off for US Exempt Employees: Flexible time off (unlimited, with manager approval) and 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico, or Rayzebio employees).
  • Paid Time Off for Phoenix, AZ, Puerto Rico, and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays.
  • Additional time off (based on eligibility) may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs, and an annual Global Shutdown between Christmas and New Year’s Day.

Schedule

This role follows an on-site protocol based on occupancy structure:

• Site-essential roles: Require 100% of shifts onsite at the assigned facility.
• Site-by-design roles (eligible for hybrid work model): Require at least 50% onsite at the assigned facility. Onsite presence is considered essential for collaboration, innovation, productivity, and maintaining a positive company culture.