Senior Process Engineer, Summit, New Jersey

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 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 a Senior Process Engineer to join our team in Global MSAT. The successful candidate will lead efforts related to tech transfer and lifecycle management thereafter. The Senior Engineer will be responsible for leading cross-departmental groups, and planning/executing risk assessments and strategy development for analytical comparability exercises to enable change implementation. This role is responsible in developing 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 Sr. Process Engineer 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 process engineers and analytical scientists and guide comparability design by applying in-depth CAR-T and viral vector manufacturing process knowledge
• Perform 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 and vector products
• Lead execution of process risk assessments, development of criteria justifications, and development of comparability protocols
• Author 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
• Lead efforts focusing on alignment and harmonization of comparability strategies across multiple sites
• Leverage and maintain strong relationships across multiple sites
• Coach/support junior staff on the team on complex technical issues

Skills/Knowledge Required :

• Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects working in a self-driven, performance/results oriented, fast paced matrix environment
• Demonstrated ability to perform/document complex manufacturing processes and provide technical support in a clinical/commercial GMP environment
• Experience in development and/or characterization of biologics and/or cell therapy manufacturing processes
• Experience with cGMP, ICH guidelines, control strategy development, and working within a Quality organization
• Excellent problem-solving skills
• Proficiency utilizing MS Office products and statistical software (R, JMP, Minitab)
• Able to creatively manage time and elevate relevant issues to project lead and line management
• Strong scientific and excellent written and verbal communication skills. Ability to convey complex technical issues to diverse audiences including internal teams, external partners, and health authorities.
• Detail oriented with excellent verbal and written communication skills

Preferred Qualifications

• Preference given to candidates with experience writing regulatory submissions
• Knowledge of cellular immunology and cell therapy experience a plus

Education Requirements

• MSc or BSc in Chemical Engineering, Biochemical Engineering or equivalent with minimum of 5-7+ years relevant technical experience in technical development, manufacturing science or other disciplines in technical operations

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 performance
• 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, 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.

BMSCART

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.