Bristol Myers Squibb Company

Process Engineer, Life Cycle Management

Location
Summit West, NJ, United States
Posted
Sep 02, 2020
Ref
R1529276
Required Education
Bachelors Degree
Position Type
Full time
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.

POSITION SUMMARY:

We are looking for an Engineer to join our Life Cycle Management Process Engineering team in Global Manufacturing Science and Technology.

The successful candidate will work on product lifecycle strategy and execution to enable the teams to sustainably deliver drug product supply. Scope of role is to prioritize lifecycle initiatives and trade off decisions and implement lifecycle management changes throughout Cell Therapy Division and Operations network. This role is a great opportunity to interface with the Product Sciences/ MSS Labs, Product specific TCT and CMC teams and Site teams to generate proof of concept for LCM projects, represent GMP site implementation interests in planning, development, and prototyping stages, and then coordinate with Site MS&T, quality, Regulatory and Steward teams throughout execution phases to communicate global strategy and share information. This is a key role that will translate product strategies into realized gains in the manufacturing network. The role is also a key interface between product teams and the manufacturing network influencing the product strategies to be a realistic balance of product goals, manufacturing capability, cost and complexity.

Duties/Responsibilities:
  • Oversee implementation of Life Cycle Management (LCM) projects and transfers between sites.
  • Develop and implement process improvement projects to improve robustness, scalability and COGs for cell therapy products
  • Partner with product technical stewards and Regulatory teams to align on LCM strategy and manage implementation
  • Ensure technical and manufacturing requirements are addressed throughout lifecycle of new solutions
  • Review technical reports and source documentation to support product lifecycle and regulatory submissions.
  • Partner with system integration teams, business process owners and other global teams to align process data handling initiatives within the LCM projects


QUALIFICATIONS

Specific Knowledge, Skills, Abilities, etc:
  • The candidate must have demonstrated verbal, written, and communication skills including ability to present complex information clearly and concisely, with a successful proven history of working with technical teams.
  • Experience should include strong knowledge and technical leadership and proven track record of managing LCM projects
  • Demonstrated leadership skills, and the ability to interact with and lead diverse groups and teams are essential.
  • Proven project management skills (organization, collaboration, multi-tasking, and communication), attention to detail, and the ability to perform well in a team-based environment are required
  • Prior experience in/knowledge of cell culture, viral vector manufacturing, recovery and/or purification of viral vector product in a manufacturing environment required
  • Strong experience with SOPs, change controls, cGMPs and the know how to work within a regulatory environment required
  • Prior experience facilitating/participating in Risk Assessments required


Education/Experience/ Licenses/Certifications:
  • Degree in Biochemical or Chemical Engineering or Sciences: Minimum of a Bachelor's degree with 6+ years of experience, Master's degree with 4+ years or Ph.D. degree with 2+ years
  • Familiarity with cell therapy processes is preferred.
  • Ability to effectively lead cross functional teams, meet deadlines, and prioritize responsibilities.
  • Experience working in a self-driven, performance/results oriented, fast paced matrix environment.
  • Excellent problem-solving skills, including issue resolution
  • Ability to assess risk and develop contingency plans for process risks
  • Able to manage time and elevate relevant issues to management and governance forums.
  • Detail oriented with excellent verbal and written communication skills.
  • Strong interpersonal and leadership skills to work with teams in different functions and organizations

Physical Demands:
  • Position requires repetitive use of hands and wrist (computer work)
  • Occasional bending, twisting and stooping to allow for gowning into classified environment required


Work Environment:
  • Position is primarily office based with occasional work in a classified GMP manufacturing environment
  • Position is a team & project-based position that will require occasional shift work, weekends, and holidays


Travel:
  • This position may require up to 25% of travel


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.