Senior Process Engineer, Cell Therapy Manufacturing, Science and Technology

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.

DEPARTMENT

Cell Therapy Global Manufacturing Science and Technology (MSAT)

Locations: Seattle WA or Summit, NJ

PREREQUISITES

Experience with tech transfer, manufacturing technical support, process development, GMP experience

Summary:

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture. Come and join Celgene for this key leadership role to be part of the team building a leading CAR T Platform that serves our patients with novel Celgene CAR T Therapies 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 the Comparability 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 tech transfer and lifecycle management. The Senior Process Engineer will be responsible for leading 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 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 Senior Process Engineer will play a key role in product lifecycle management, including development, characterization, commercialization, and evolution of cell therapy products.

The roles and 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 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 products
• Lead execution of process risk assessments, development of criteria justifications, and development of comparability protocols
• Author and review 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)

Basic Qualifications

• B.S. or M.S. in Chemical Engineering, Biochemical Engineering or equivalent with 7-10 years relevant experience in biologic or cell therapy process/analytical development or commercial manufacturing process technical support
• 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
• 3+ years of experience working in a GMP environment, 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 escalate relevant issues to project lead and line management
• Strong scientific and technical writing
• Detail oriented with excellent verbal and written communication skills

Preferred Qualifications:

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

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.