Bristol Myers Squibb Downstream Process Engineer, Manufacturing Technology in Devens, Massachusetts
• Individual will function as a downstream subject matter expert (SME) for large-scale commercial manufacturing involving column chromatography, microfiltration, ultrafiltration, nanofiltration, and cryogenics / drug substance handling unit operations.
• Support remediation of complex manufacturing process deviations through non-routine troubleshooting, investigations, identification of CAPA, and implementation of change controls
• Support cross site or cross department technology transfers. Support process scale up efforts (facility fit, gap and risk assessments) and program start up efforts. May include leadership of upstream, downstream and/or cryogenics/drug substance handling transfer.
• Support process validation studies, process improvement studies, and/or process capability studies.
• Support continuous improvement and process robustness efforts. Support and implements innovation projects to optimize process performance.
• Partnering with laboratory teams, engage in the design of experimental studies to address manufacturing deviations, increase process robustness, and/or optimize output/product quality.
• Support authorship of CMC regulatory submissions (BLA, MAA, PAS) and responses. May function as a process SME during inspections and interactions with regulatory authorities.
• Support cross-functional project teams (Manufacturing, Quality Assurance, Regulatory, and Supply Chain) for facility-fit analyses, technical assessments, and change management
• BS/MS in the biological sciences or chemical/biochemical engineering, a related discipline, or its equivalent with 4-6 years (BS) or 2-4 years (MS) experience of relevant industrial and/or academic experience.
• Preferred experience: biologics process development (purification), process validation, and/or manufacturing.
• Proficiency of SOPs, cGMPs and the know how to work and manage within a regulatory environment.
• Experience in successful execution and management of process technical transfer.
• Experience in designing and executing process and equipment validation plans.
• Experience in the design, modification and optimization of biologics purification unit operations.
• Experience in investigating process deviations and developing issue resolving CAPAs.
• Proven project management skills and effectively balancing project assignments with other duties.
• Experience with biopharmaceutical regulatory submissions and interaction with regulatory agency inspectors.
• Critical qualities include a high degree of initiative, excellent verbal and written communication skills, strong scientific skills, and the ability to work independently and in a team environment.
• Interpersonal and facilitation skills are necessary to interface with and influence stakeholders across the organization.
• Principal assignment is in a modern LSCC building which requires adherence to various Personal Protective Equipment (PPE) standards.
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.