Specialist, Manufacturing Technical Development
Bristol-Myers Squibb (BMS) · Summit West - NJ - US
Job description
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary The 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 Responsibilities Training 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 Conditions This 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 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. 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 volu
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