Downstream Process Engineer, Manufacturing Technology
Company: Bristol-Myers Squibb
Location: Devens, Massachusetts
Posted: September 08, 2017
Reference ID: 1703467
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.
The Process Engineer / Scientist in the Manufacturing Technology (MT) team within Manufacturing Sciences & Technology (MS&T) is a senior member of the MT team and will serve as a technical leader and subject matter expert in the area of purification supporting late-stage and commercial manufacturing of biologics drug substance. The successful candidate will be a key contributor to a highly technical, diverse, and collaborative team of scientists and engineers by setting appropriate objectives and action plans, overcoming obstacles, and delivering results to meet established timelines. The Engineer / Scientist contributes to cross-functional teams to meet highly visible business objectives. This position offers the opportunity to interface with Manufacturing, Engineering, Process Development, Quality, Analytical, and Global Regulatory Sciences groups.
• Individual will function as the downstream subject matter expert (SME) for large-scale commercial manufacturing involving column chromatography, microfiltration, ultrafiltration, nanofiltration, and cryogenics / drug substance handling unit operations.
• Function as technical lead within the team driving remediation of complex manufacturing process deviations through non-routine troubleshooting, investigations, identification of CAPA, and implementation of change controls
• Lead cross site or cross department technology transfers, functioning as project owner and accountable person. Lead process scale up efforts (facility fit, gap and risk assessments) and program start up efforts. May include leadership of upstream, downstream and raw materials/consumables transfer.
• Lead process validation studies, process improvement studies, and/or process capability studies.
• Lead continuous improvement and process robustness efforts. Leads and implements innovation projects to optimize process performance.
• Partnering with laboratory teams, lead the design of experimental studies to address manufacturing deviations, increase process robustness, and/or optimize output/product quality.
• Author CMC regulatory submissions (BLA, MAA, PAS) and responses. Represents the manufacturing site as process SME during inspections and interactions with regulatory authorities.
• Lead cross-functional project teams (Manufacturing, Quality Assurance, Regulatory, and Supply Chain) for facility-fit analyses, technical assessments, and change management.
• Potential to supervise and mentor junior employees or contractors.
• PhD or MS/BS in Biochemistry, Chemical Engineering, or related field with 0-2 years (PhD), 4-6 years (MS), or 8 years (BS) experience of relevant industrial and/or academic experience.
• Preferred experience: biologics process development (purification), process validation, and/or manufacturing.
• 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
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.