Job Description

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 BMSs continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.

We are looking for a Process Engineer join the Comparability Team within the Cell Therapy GMS&T (Global Manufacturing Science and Technology) department. The successful candidate will collaborate with the GMS&T teams at the Seattle and New Jersey locations and support efforts related to tech transfer and lifecycle management. The Process Engineer II/III will be responsible for supporting cross-departmental teams, and planning/executing risk assessments and strategy development for cell therapy analytical comparability exercises to enable change implementation.

This role is responsible for supporting the development of study design and statistically derived criteria to evaluate pre-change and post-change results and summarize the strategy in technical protocols and results in technical reports. This person will collaborate across all CMC functional areas to insure project advancement, rapid and best in class execution, and communication of challenges/opportunities. The Process Engineer II/III will play a key role in product lifecycle management, including development, characterization, commercialization, and evolution of cell therapy products.

Responsibilities include, but are not limited to, the following:

* Collaborate with analytical scientists and support comparability design by applying CAR-T manufacturing process knowledge
* Support statistical analysis of product attribute data as well as statistical tests and evaluation to assist the design and execution of comparability exercises for cell therapy products
* Support execution of process risk assessments, development of criteria justifications, and development of comparability protocols
* Supporting the data verification and authoring regulatory filings summarizing the strategy and results from comparability exercises
* Develop, understand, and manage tools and templates that can be used to quantify potential impact of changes on process performance and product quality
* Contribute to alignment and harmonization of comparability strategies across multiple sites
* Leverage and maintain strong relationships across multiple sites
* Up to 10% travel may be required (primarily domestic travel)

Skills/Knowledge Required:

* B.S. with 3-7 years with relevant experience in Biochemical, Chemical, or Biomedical Engineering
* Experience in a regulated manufacturing environment (clinical and/or commercial)
* Experience with cellular therapies is strongly preferred
* Experience with technology transfer is strongly preferred
* Experience with change control is strongly preferred
* Track record of success with sound technical qualifications and knowledge in process development, characterization, and troubleshooting
* Ability to assess risk and develop contingency plans for process risks
* Excellent communication, writing, organizational, teamwork, and presentation skills
* Strong interpersonal and leadership skills to work with teams in different functions and organizations

Additional Skills:

* Create an environment of teamwork, open communication, and sense of urgency
* Drive strong collaboration within the group and across functions
* Build trust and effective relationships with peers and stakeholders
* Foster a culture focused on inclusion, solid science, compliance and strong environmental, health, and safety performanc
* Have a mindset of continuous improvement, problem solving, and prevention

If you want to challenge yourself, accelerate your career, and give new hope to patients, theres 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.