Principal Process Engineer

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.

Principal Engineer (2nd Generation Lisocell Vector Transfer)

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, immunotherapy and fibrosis. Our cell therapy platforms are based on two distinct and complementary technologies Chimeric Antigen Receptors (CARs) and T-Cell Receptors (TCRs). Our goal is to revolutionize medicine by re-engaging the body's immune system to treat cancer.

Come and join the BMS Cell Therapy Development and Operations (CTDO) Division and be a part of the team building leading cell therapy platforms to serve our patients with novel cellular immunotherapies. The Global Manufacturing Science and Technology (GMSAT) Division of CDTO plays a critical role in technology transfers, process validation, CMC life cycle management, technical oversight of external manufacturing partners, process engineering and establishing manufacturing standards to enable a robust and scalable global cell therapy manufacturing network. We are looking for a Principal Process Engineer to join our Vector & Gene Delivery MSAT group in Global MSAT. This role may also be filled as a Senior Engineer depending on candidate selection.

The successful candidate will lead efforts related to transfer of vector manufacturing technologies from process development to GMP manufacturing and have responsibilities of lifecycle management thereafter. The Principal Process Engineer will be responsible for overseeing the transfer of technologies, including cross-departmental collaboration to enable facility fit, development of process documentation (Batch Records, Forms, etc.), training of personnel, change control ownership, and other quality system related deliverables. This person may be responsible for and support processes from early clinical phase through development of PPQ strategies and commercial manufacturing support. 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 Principal Process Engineer will play a key role in product lifecycle management, including strategic development, characterization, commercialization, and evolution of cell therapy products.

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.

Direct Reports:

Yes (1)

PRIMARY RESPONSIBILITIES:

• The initial focus area for this position is to support vector process technical transfer to a CMO partner for a commercial product
• Some travel may be required once restrictions resulting from the Covid-19 pandemic are lifted
• Lead process and technology transfers, change management, and technical process support for cell therapy product vector process intermediates
• Lead development of process control strategies including execution of process risk assessments, development of range justifications, and development of continued process verification strategy
• Author regulatory filings across product lifecycle
• Perform and support data monitoring of manufacturing processes to understand process capability, troubleshoot investigation-driven events
• Develop, understand, and manage tools and templates that can be used to quantify impact and criticality for parameters and attributes within manufacturing unit operations
• Support design activities for clinical and/or commercial facilities
• Lead efforts focusing on alignment and harmonization of manufacturing process across multiple sites
• Leverage and maintain strong relationships with external partners
• Coach/support junior staff on the team on complex technical issues

REQUIRED QUALIFICATIONS:

• Proven track record of interacting with CMOs, both domestic and foreign
• Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects
• 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, PPQ (process validation), control strategy development, and working within a Quality organization
• Experience working in a self-driven, performance/results oriented, fast paced matrix environment
• Excellent problem-solving skills
• Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab)
• Able to creatively manage time and elevate 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 and participating in interactions with health authorities
• Knowledge of cellular immunology a plus
• Experience with disposable technologies such as SUBs and SUMs
• Experience with cell culture process characterization and validation
• Experience managing CMO relations, including creation of statements of work, master service agreements, budgeting and timeline management

EDUCATION REQUIREMENTS:

• PhD, MS or BS in Chemical Engineering, Biochemical Engineering or equivalent. Minimum of 10 years relevant experience (PhD) or 15 years (MS/BS) in biologic process development or commercial biologic manufacturing process support.

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.