Principal Scientist, Manufacturing Technology, Process Transfer and Validation

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Position Summary

BMS Devens Biologics is recruiting a Principal Scientist, Manufacturing Technology, Process Transfer and Validation. This role reports to the Associate Director, Manufacturing Technology, Process Transfer and Validation within the Manufacturing Technology (MT) department which is part of the wider Manufacturing Science & Technology (MS&T) organization. The MT department supports a large-scale highly automated multi-product cell culture (MPCC) facility on a growing campus. The Principal Scientist, Manufacturing Technology, Process Transfer and Validation supports ongoing manufacturing /technology transfers through routine process monitoring. The successful candidate will be a key contributor in a dynamic and highly collaborative team environment. The candidate will manage objectives and priorities, overcome obstacles, and deliver investigations within projected timelines.

Key Responsibilities

• Provide technical support to commercial manufacturing processes with a focus on enhancing the business through increased process robustness and yield increase programs of activity.
• Manage 2-5 permanent and/or contract employees.
• Lead / support technology transfer activities.
• Manage execution of Manufacturing Technology projects.
• Support continuous improvement and efficiency / process optimization projects.
• Implement efficient business processes for MT through standardization of work practices and continuous improvement.
• Develop best practices for technical strategies.
• Implement and maintain high standard of quality and regulatory compliance to meet and exceed regulator agency and quality requirements.
• Liaise with MS&T and network functions to implement technical and operational improvements.
• Optimize resource allocation to address MT deliverables and priorities.
• Invest in the development of current and future leadership through assignment of development opportunities, coaching, mentoring, and recognition.
• Leads the preparation of regulatory filing documents and inspection readiness.
• Demonstrates a strong knowledge of cGMP compliance, BMS corporate, site and regulatory agency requirements and procedures.
• Design and execution /or delegation of plant supporting studies and /or technical studies on the manufacturing floor at commercial scale.

Qualifications & Experience

• Bachelor of Science (BSc), Bachelor of Engineering (BEng) or equivalent in the biological sciences or chemical / biochemical engineering or a related discipline, along with experience in commercial manufacturing, PhD (> 4 years), MS (> 6 years), BS (> 8 years) documented by a solid history of technical accomplishments.
• Familiarity of SOPs, cGMPs and the know how to work and manage within a regulatory environment.
• Proven project management skills that include leading cross functional teams.
• Knowledge of mammalian-based biologics manufacturing processes is preferred.
• Good communication, organizational, presentation and multi-tasking skills.

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.

Uniquely Interesting Work, Life-changing Careers
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