Associate 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 Associate Process Engineer provides technical leadership related to new and existing sterile drug products. This position is supports the technical interface with R&D to ensure design and transfer of robust manufacturing processes for new products and key life cycle management products, development of new technology for optimization and continuous improvement in manufacturing operations, providing specialized expertise as necessary to complement site capabilities for critical investigations or process improvements, setting relevant standards and creating and maintaining associated Directives (e.g, for tech transfer, Product monitoring, etc).

MAJOR DUTIES AND RESPONSIBILITIESSupport drug product technology transfers, interfacing with R&D and internal sites or Contract Manufacturing Organizations (CMO’s) for new product development teams. Partner with R&D to ensure manufacturing processes are developed for optimal execution within the Manufacturing and Supply network or designated 3rd parties. Support product champions for parenteral drug product assets and owners to identify process robustness risks for key products, develop monitoring plans and risk mitigation and recommend options. Support Drug Product aspects of the Technical Roadmap/Agenda for inline biologic drug products. This entails prioritization of process and analytical changes to optimize process performance and efficiency over the lifecyle of the product. Support/lead execution of post-market process change activities through partnership with R&D development assets. Provide technical justification and direction to enable change control and resolution of key investigations at Contract Manufacturing Organizations (CMO’s). Assess both internal and external manufacturing capabilities against current BMS and industry technical standards for advanced commercial aseptic processing. Interact and engage with a core team of specialized experts with necessary capabilities to support the BMS portfolio of products and complement site capabilities. Provide assistance to sites globally to resolve significant quality events and manage complex change controls. Work with R&D and manufacturing sites to develop and execute strategy for leveraging new innovative technologies to bring value-driven innovation to site operations. Review and co-author sections of the CMC filing (US and ROW). Identify product cost drivers and identify opportunities for cost reduction early in product/process development or as part of post filing improvements.

Qualifications:


Bachelor’s degree in biomedical or mechanical engineering or related field



0-2 years of experience in the Pharmaceutical or Biotechnology industry in the commercialization/tech transfer of biologics drug products and/or medical device field.


Key Skills and Experience


Knowledge of parenteral/sterile manufacturing

Understanding of project management systems and tools

Working competency of Statistical Process Control and related tools.

Very strong analytical, technical writing, verbal communication

Ability to influence areas not under direct control to achieve objectives


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

Sign Up Now - WashingtondcCrossing.com