Bristol Myers Squibb Senior Specialist, Engineer II in Seattle, Washington
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS’s continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.
Job Purpose / Position Summary
BMS Cell Therapy organization is developing novel cellular immunotherapies based on two distinct and complementary platforms – Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body’s immune system to treat cancer.
We are looking for an Engineer I/II to join the External team within the Cell Therapy GMSAT (Global Manufacturing Science and Technology) department. The successful candidate will collaborate with the GMSAT teams in Seattle and New Jersey locations in the US and support efforts related to the tech transfer of cell therapy manufacturing technologies to external CMOs around the world. The Engineer I/II will be responsible for the implementation of technologies, including cross-departmental collaboration to enable facility fit, development of process documentation (Batch Records, Forms, etc), e-systems deployment, inspection readiness, process validation, and training. This Engineer I/II will have responsibilities similar to an internal cell therapy drug product MSAT position with focus on supplementing the technical capabilities of the CMO according to local regulations. This person will support processes from early clinical phase through commercial manufacturing support, and lead portions of the tech transfer to CMOs. The Engineer will support product lifecycle management, including commercialization and evolution of cell therapy products as well as day to day operations technical support at CMOs to ensure reliable quality supply. The role will be highly cross-functional and will interact with other CTDO/GPDO groups and in-country affiliates to establish manufacturing and technology capabilities, CMO due diligence and selection, facility fit and design, equipment selection, risk assessments, and facility start up work force training.
Responsibilities include, but are not limited to, the following:
Support process and technology transfers, change management, and provide technical process support for routine clinical and/or commercial cell therapy products at the CMO. Lead certain components of technology transfer, protocols, reports, etc.
Implement and support the execution of process control strategies including execution of process risk assessments, and continued process verification
Support production related investigations, ensuring compliance with internal standards and regulatory requirements
Perform monitoring of manufacturing processes to understand process capability
Develop, understand, and manage tools and templates that can be used to quantify impact and criticality for parameters and attributes within BMS and/or CMO unit operations
Support design activities for clinical and/or commercial facilities
Leverage and maintain professional relationships with external partners
Support product implementations in coordination with Development, Manufacturing, and Quality groups, including visits to contract manufacturing sites
Support permanent inspection readiness and actively support regulatory inspections
Ensure manufacturing processes are in a state of control, harmonized across the cell therapy manufacturing network
Develop, execute manufacturing process improvement activities in accordance with the overall life cycle plan for the product
Share operational and process learning with the rest of the manufacturing network
Provide necessary technical analysis to enable decisions related to new raw materials or selection of CMOs
Support and implement continuous improvement for technical and business processes
Skills/Knowledge Required :
B.S. or M.S with 2-4 years of relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline
Experience with cellular therapies is highly preferred
Extensive experience in a regulated manufacturing environment
Flexibility to work within manufacturing schedules
Familiarity with literature on process development and cell therapy
Ability to assess risk and develop contingency plans for process and business risks
Excellent communication, writing, organizational, teamwork, and presentation skills
Exceptional interpersonal and leadership skills to work with teams in different functions and organizations
May require 10-25% travel depending on stage of project
Japanese language skills is a plus
If you want to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients’ lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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 with the resources to pursue their goals, both at work and in their personal lives.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Company: Bristol Myers Squibb
Req Number: R1543367
Updated: 2021-08-03 02:57:11.808 UTC
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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.