Bristol Myers Squibb Company

Process Engineer I

Location
Celgene, NJ, United States
Posted
Sep 10, 2020
Ref
R1529494
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.

Come and join Bristol Myers Squibb for this key role helping to build a leading CAR T Platform that serves our patients with novel CAR T Therapies. At BMS, we are 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.

  • Global Manufacturing Sciences and Technology is responsible for tech transfer, support and harmonization of Cell Therapy Manufacturing Processes across the manufacturing network throughout the product life-cycle from pre-clinical through commercial manufacturing.


  • The Manufacturing Sciences Support team provides technical and lab-based support for clinical and commercial manufacturing. Leading and/or supporting process investigations, raw material changes, consumable changes and process improvements which increase operational efficiency in manufacturing in order to improve capacity to deliver life-saving therapies to patients. Additionally, the team executes process comparability and validation studies to support regulatory filings.


The Process Engineer will play a key role in ensuring successful manufacture of life-saving cell therapy products. The primary focus of the Process Engineer will be to support testing and implementation of operational improvements and resolve manufacturing process investigations at the BMS cell therapy GMP manufacturing facility. The engineer will be part of a team tasked with determining the root cause of manufacturing investigations. This individual will design and execute experiments, evaluate data and draft technical reports in support of improvement, investigations and manufacturing process changes. The Process Engineer will also contribute to well controlled comparability and validation studies which enable regulatory filings for raw material and process changes.

Major Duties Include:
  • Design and execute experiments in the process development labs which includes aseptic processing and operation of automated process equipment.
  • Summarize experimental data and aid in analysis to draw conclusions.
  • Participate in Root Cause Analyses to determine cause of manufacturing process investigations.
  • Coordinate with the analytical group for timely delivery of process samples and turn-around of analytical data.
  • Support production related investigations, ensuring compliance with internal standards and regulatory requirements.
  • Develop and execute manufacturing process changes and improvement activities, and/or author technical reports for process changes and improvements.
  • Support process comparability and process validation studies including planning, execution and documentation management. Support necessary technical experiments and analysis to enable decisions related to raw materials changes.
  • Contributes to ownership and advancement of work processes, and procedures.
  • Flexibility with work schedule as maintenance of cell cultures on occasional weekends, early mornings, or evenings is required


Required Qualifications:
  • Degree in Biological Sciences, Chemical Engineering, Life Sciences or related discipline.
  • BS degree with minimum of 4+ years of relevant experience, or MS degree with minimum 2+ years of relevant experience in biologic process/analytical development or commercial biologic manufacturing process support.
  • Excellent documentation skills and attention to detail with cGMP experience a plus.
  • Ability to effectively work in 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.
  • Able to creatively manage time and elevate relevant issues to project lead and line management.
  • Strong scientific and technical writing with excellent oral communication skills.


Preferred Qualifications:
  • Experience with cell therapy process development or manufacturing
  • Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab)
  • Experience executing investigations in support of commercial manufacturing
  • Experience with commercial product support, i.e. post-marketing commitments, on-going validation and comparability
  • Combination of experience in process development, MSAT and quality.
  • Operational excellence training/background


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.