Senior Engineer I, Tech Transfer

Role Summary

The Senior Engineer I, Tech Transfer is responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply at the BMS Manufacturing Facility in Bothell, WA. The Senior Engineer I, Engineering/Process will be a site subject matter expert on the cell therapy allogeneic product and the aseptic filling process within the Cell Therapy Lifecycle Management team under the Bothell Manufacturing Sciences and Technology (MSAT) department. The Senior Engineer I, Tech Transfer oversees and participates in a variety of cross-functional teams that support strategy, development and implementation of new allogeneic systems, critical reagents, and process changes. The Senior Engineer I, Tech Transfer will also support change management requests for the New Product Introduction program at the BMS Manufacturing facility. The Senior Engineer I, Tech Transfer will ensure the completion of all deliverables and support the transfer of the allogeneic process, critical to ensure successful transfer of a new product to the facility.

Responsibilities

• Subject matter expert for allogeneic process and equipment use case and change management.
• Process workstream lead for the introduction of the allogeneic drug product and aseptic filler. Leads complex projects and initiatives for the broader site and organization.
• Leads cross-functional process team for new product introduction changes, with specialized focus for allogeneic product and aseptic filling.
• Masters utilization of existing technical tools, business practices and procedures. Supports the design and implementation of new tools and makes improvements to existing programs and procedures as applicable.
• Enforces the team processes when appropriate, supporting the understanding of benefits and tradeoffs of decisions.
• May be relied upon for support in Aseptic and Environmental Control, including isolator sterilization processes, as process SME.
• With mastery, follows change management procedures, standards, policies and directives, delivering a consistent flow of ongoing support production.
• Ensures completion of all change management deliverables.
• Facilitates working sessions and authors technical documentation in support of tech transfer, including but not limited to protocols, risk assessments, and reports.
• Quickly learns from others. With some frequency, proactively supports other team members and helps them to be successful.
• Excels in demonstrating one of the BMS values (Integrity, Innovation, Passion, Urgency, Inclusion, Accountability) and works to address perceived deficiencies.
• Supports the completion of quality records (DEV, CAPA, CR), GMP training, and continuous improvement initiatives.

Qualifications

• Required: Bachelor's Degree in life sciences/engineering or equivalent
• Required: 5+ years of relevant experience
• Required: Experience in the cell therapy industry, including aseptic processing such as filling equipment, isolators, and sterilization processes.
• Required: Ability to assess risk and develop contingency plans for process risks.
• Preferred: Project And Program Management Experience Strongly Preferred