Position SummaryThe 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 and assesses their ability to perform tasks proficiently. The Specialist may also perform cleanroom processing duties as a Manufacturing Associate as needed.
Required Qualifications- Bachelor's degree in Biology, Biochemistry, Chemical, or Biomedical Engineering, or a related discipline, with 4-5+ years of relevant experience in a clinical laboratory or blood/cell culture processing environment.
- High level of understanding of cell therapy processes, controls, and GMP requirements.
- Intermediate skills in the design, development, and implementation of training.
- Advanced proficiency in Microsoft Word, PowerPoint, and Excel.
- Strong organizational and time management skills.
- Ability to communicate information clearly to facilitate effective learning, including speaking in classroom settings.
- Strong interpersonal skills that enable effective collaboration with trainees, colleagues, and subject-matter experts.
- Ability to work in an aseptic environment, including successful completion of a qualification program.
Duties and ResponsibilitiesTraining Program Implementation
- Collaborate with the Manager to create training and development plans that address production demands, ensuring new hires become proficient operators in a timely manner.
- Work with the Manager on an ongoing basis to implement training goals and meet KPIs.
- Conduct ILT and OJT sessions to ensure cleanroom operators are proficient.
- Provide feedback to trainees to confirm all skills and knowledge have been acquired; communicate any gaps requiring additional training.
- Solicit feedback from trainees to evaluate course content appropriateness and identify continuous improvement opportunities.
- Collaborate with the Manager to ensure training is compliant and effective.
- Maintain accurate training documentation and employee records.
- Seek feedback from Department Management to assess training needs and identify areas for improvement.
- Develop course content and procedures, including new SOPs and TRNs for manufacturing training programs as necessary.
- Collaborate with the Manager and Quality to identify trends that may require amendments to training programs.
- Develop and implement new course content as procedures change or new techniques are introduced.
- Perform ongoing competency assessments of operators to ensure the continuous application of skills and knowledge from training.
New Hire Onboarding
- Promote and exhibit core BMS values in all onboarding and training activities.
- Develop on-the-job training schedules that accommodate individuals with varying levels of experience while adhering to all regulatory and technical requirements.
- Perform administrative tasks including scheduling training sessions, ordering supplies, coordinating enrollment, and completing documentation.
- Conduct ILT/OJT structured trainings for new hires on aseptic processing, GMP environments, and process training.
- Communicate with departments to ensure new hires have access to all necessary systems and security clearances.
- Maintain the training status of new hires and communicate progress to Department Management.
Training Laboratory 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 and escalate deviations as appropriate.
- Perform routine cleaning of laboratory areas and equipment.
- Ensure sufficient laboratory supplies are available for daily training activities.
Manufacturing (As Needed)
- Execute batch records in ISO 7 & 8 cleanroom environments.
- Observe, practice, and promote all aspects of GMP and 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 operations; escalate any safety or product quality issues through the appropriate channels.
- Collaborate with internal teams to drive process improvements and assist with the implementation of changes utilizing quality systems.
- Report and initiate non-conformances and participate in follow-up investigations as necessary.
- Perform all other duties as required.
Working ConditionsThis role requires the ability to perform frequent physical tasks requiring strength and mobility, including extensive walking, standing, and occasional lifting of heavy materials. Frequent visual demands include both macroscopic and microscopic observations.
Employees must work in areas where Universal Precautions are posted and must be observed and practiced. Associates work daily with potentially harmful and/or hazardous agen
Compensation Overview:Summit West - NJ - US: $38.12 - $46.20per hour
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 https://careers.bms.com/life-at-bms/.
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.
