Upstream Process Engineer

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

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.

Responsibilities:

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.

Requirements:

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

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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com