Position Summary

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. 

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

Shift Differential: 10%

Duties/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.

• Performs all other duties as required.

Reporting Relationship

• Manufacturing Technical Development Manager

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.
• Requires strong interpersonal skills, which enable appropriate 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.

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. 

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit
 

Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include:

• 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

• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)

• 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

Based on eligibility*, additional time off for employees 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 Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.