Process Engineer I
About the Job
At Bristol-Myers Squibb, we believe that together we can make the difference. We want to do this by building professional teams who can create and innovate medicines that benefit doctors and their patients.
Our large-scale biologics manufacturing facility in Devens, Massachusetts, is expanding and there are a number of exciting career opportunities to join Bristol-Myers Squibb, one of the world’s leading BioPharma companies.
We’ve created one of the world’s premier biologics facilities, among the first sites in the industry to have a fully automated, integrated manufacturing control system that enables the plant to run virtually paperless. It is a site that combines biologics development with clinical and commercial manufacturing on a single campus – a true biologics center of excellence for the company where teams are encouraged to closely collaborate. This expansion was designed to support the launch of new medicines by more closely aligning biologics development and manufacturing capabilities. All this goes towards helping create and innovate life-saving medicines that fight serious illnesses.
As a part of Manufacturing Science and Technology group, the Upstream Process Engineer drives technology transfers of novel biologics drug molecules from lab-to-commercial scale, identifies and implements process/operational improvements and provides process support to BMS biologics manufacturing operation to ensure stable supply of medicines to patients.
The successful candidate will be a key contributor in a fast-paced, dynamic and highly collaborative team environment. The candidate will set appropriate objectives and priorities, overcome obstacles, and deliver results within project timelines. Expertise and experience in the design, control, and operation of large scale inocula, seed train, bioreactor, filtration, and centrifugation unit operations are highly desirable. Demonstrated skills in cross-functional partnerships and knowledge of regulatory and cGMP requirements are required. This position offers the opportunity to provide highly visible technical leadership to resolve complex problems while meeting quality, schedule, and cost objectives.
- Serve as a process technical and subject matter expert to large scale cell culture and harvest unit operations for the commercial manufacture of biopharmaceuticals by drawing on the experience with\: data analysis, mammalian cell culture process theory and equipment, univariate and multivariate statistical process control, GMP processes, and regulatory submissions.
- Supports commercial manufacturing via in-plant coverage and real-time process upset troubleshooting
- Evaluate process performance by comparing manufacturing data to historical data through univariate and multivariate techniques with recommendations generated for process enhancement strategies for technical and operational improvements, investigation resolution, and process validation.
- Coordinate aspects of process technology transfer, process validation and the preparation of CMC documentation for regulatory filings and responses for the BMS Devens commercial manufacturing facility through cross-functional leadership and individual technical contribution.
- Provide process subject matter expertise for regulatory inspections and other interactions with regulatory agencies. Actively communicate group’s activities and progress through varied technical and non-technical forums.
- Provide technical expertise for investigation and resolution of upstream process deviations, root cause investigation, CAPAs, process improvements, review and approval of change controls and preparation of regulatory filings.
- PhD degree in Engineering, Chemical Engineering, Biotechnology or related field plus 0 to 2 years
- Master’s degree in Engineering, Chemical Engineering, Biotechnology or related field plus 5 years of post-baccalaureate experience reflecting demonstrable ability in the skill set described above. In lieu of Master’s degree and 5 years of experience, employer will accept Bachelor’s degree in Engineering, Chemical Engineering, Science or related field plus 8 years of post-baccalaureate experience reflecting the demonstrable ability in the skill set described above
- Experience or knowledge in execution and management of process technical transfer
- Experience or knowledge in designing and executing process and equipment validation plans
- Experience or knowledge in the design, modification and optimization of biologics cell culture unit operations
- Knowledge in investigating process deviations and developing CAPAs
- Proven project management skills and effectively balancing project assignments with other duties
- Experience with biopharma regulatory submissions and interaction with regulatory agency inspectors
- Excellent verbal & written communications skills
- Interpersonal and facilitation skills necessary to interface with and influence all levels of the organization with the ability to lead people and multi-disciplinary teams
- Principal assignment is in a modern LSCC building which requires adherence to various Personal Protective Equipment (PPE) standards
Together, we make a difference. Bristol-Myers Squibb is one of the world’s BioPharma leaders, committed to delivering innovative medicines as well as nurturing a culture that’s a springboard for progress. Our success depends on building teams of bold, innovative and passionate employees who will help continue to drive us further forward. No matter the role, we are united by our mission and determined to win this fight. And that makes all the difference. If you want to join us, apply now at www.bms.com/careers.