Senior Specialist, Engineer II, External MS&T - Bristol Myers Squibb

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Title: Senior Specialist, Engineer II, External MS&T

Location: Warren, NJ or Summit, NJ

The Senior Specialist, Engineer II, External MS&T is responsible for supporting the production of personalized cell therapy products for both global clinical and commercial supply for CMOs and collaborate with the US-based Cell Therapy Technical Organization's External MS&T team to lead efforts related to technology transfer and continuous commercial manufacturing of BMS cell therapy products while being based in US. The engineer will support CMOs including creation, changes, and enhancements to process documentation (batch records, work instructions, SOPs, etc.) occurring at CMOs. The person will be responsible include (a) providing day-to-day manufacturing support, (b) leading manufacturing investigations pertaining to the process control strategy and associated elements, (c) managing multidisciplinary projects aimed at improving the process and/or drug product life cycle sustainability, (d) managing CPV and process monitoring program, and (e) support development and lifecycle management of MBR, MES, and/or eBR . These areas include creation/revision of documentation (i.e. SOP, change control, validation documentation, technical reports, etc.) required to support the production of personalized cell therapy products. This engineer will work closely with a cross-functional team of members from QA and external manufacturing to support all MSAT related activities at CMOs.

Key Responsibilities:

• Provide technical process support for on-going manufacturing, routine clinical and/or commercial cell therapy product.
• Review and approve manufacturing batch records, change controls, and deviations authored by the CMO.
• Review executed batch records to ensure process is operating within the validated state
• Work with technical and quality teams at CMO to evaluate and implement process improvements
• Author risk assessments, study protocols, and technical reports and revise process documents as needed to support technology transfer and process changes
• Perform and support data monitoring of manufacturing processes to understand process capability, resolve production issues and troubleshoot investigation-driven events
• Ensure the manufacturing process is in a state of control, through an understanding of CPV data.
• Support production related investigations, ensuring compliance with internal standards and regulatory requirements.
• Support the change initiatives and the implementation of process improvement initiatives.
• Participate on project teams to help prepare project schedules, execute technical projects and develop presentations to project stakeholders and senior management.
• Leverage and maintain strong relationships with external CMOs and their vendors, peers and stakeholders.
• Support permanent inspection readiness and actively support regulatory inspections.
• Develop, execute manufacturing process improvement activities in accordance with the overall life cycle plan for the product.
• Share operational best practices and process learning with the rest of the manufacturing network.
• This position requires up to 25% of travel

Qualifications & Experience:

• Master’s or Bachelor’s Degree in Chemical Engineering, Biochemical
• Engineering or equivalent with minimum of 1-3 years relevant experience in
• biologic process/analytical development or commercial biologic manufacturing process support.
• Experience with cell culture or aseptic techniques is preferred.
• Experience in a regulated, GMP manufacturing environment is required.
• Experience with cGMP, ICH guidelines, PPQ (process validation), and working within a Quality organization.
• Operational Excellence and Lean Manufacturing training/background is preferred.
• Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects.
• Demonstrated ability to perform/document complex manufacturing processes and provide technical support in a clinical/commercial GMP environment.
• Excellent communication, writing, sense of urgency, teamwork, and presentation skills.
• Excellent problem-solving skills
• Experience working in a self-driven, performance/results oriented, fast paced matrix environment.
• Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab)
• Able to creatively manage time and elevate relevant issues to project lead and line management.
• Strong interpersonal skills required to work with teams in different functions and organizations.
• Detail oriented with excellent verbal and written communication skills.

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With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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