Bristol Myers Squibb Company

Process Engineer II or III, Apheresis Technical Support

Location
Celgene, NJ, United States
Posted
Aug 31, 2020
Ref
R1525816
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.

Position Summary

Bristol-Myers Squibb 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 Process Engineer II or III to join the External Manufacturing, Science and Technology team within the Cell Therapy GMSAT (Global Manufacturing Science and Technology) department. This position will provide technical support to Apheresis collection centers across US, EU and AP regions for multiple programs. In this role, the candidate will closely collaborate with the Apheresis Operations and Quality Assurance (QA) teams in Seattle/ New Jersey to ensure cross-functional alignment is achieved on all continuous improvement decisions.

The candidate will provide Subject Matter Expertise (SME) support for the successful resolution of investigations and CAPAs associated with events at global apheresis collection sites. The candidate will assume responsibility for evaluation of new collection equipment and supporting any feasibility studies for implementation across collection centers. The candidate will need to understand how Apheresis equipment parameters are set relative to the collection requirements for a particular product. The candidate will provide routine support to global requests coming from the Apheresis Operations team for managing events/excursions that occur during the collection process. The candidate will be responsible for review, updates, approval and harmonization of collection manuals across global collection centers, while working with stakeholders in Apheresis Operations and QA. The candidate will also support performing gap/impact assessments, and risk assessments to harmonize operations across Apheresis sites.

For new products, the candidate will work with development teams to establish requirements for the collection process through an impact assessment to align with desired drug product CQAs. The candidate will be responsible for setting up and conducting proactive process monitoring for Apheresis material and perform statistical analysis and/or multivariate analysis. The candidate will summarize data trends from proactive process monitoring and recommend actions if required for continuous improvement.

Responsibilities include, but are not limited to, the following:
  • Technical Support for requalification of global Apheresis sites through analysis of site-specific data.
  • Define collection equipment, methods and parameters for new products with development teams and medical teams.
  • Provide quality systems support for investigations, ensuring compliance with internal standards and collection site requirements.
  • Perform monitoring of collection processes to understand process/equipment capability.
  • Understand industry trends and identify any new assays needed for fully describing Apheresis product quality.
  • Develop, understand, and manage tools and templates that can be used to correlate the impact of collection parameters on downstream unit operations, i.e., drug product attributes.
  • Develop, run and report Apheresis metrics and KPI in stakeholder meetings.
  • Leverage and maintain strong relationships with global Apheresis sites.
  • Ensure collection processes are in a state of control, harmonized across the entire network of Apheresis sites, to the extent possible.
  • Share operational and collection process learnings across the entire network of Apheresis sites.
  • Knowledge of applicable regulations and standards.
  • Approximately 30% travel (domestic and international) to Apheresis sites.


PE II - Skills/Knowledge Required:
  • B.S. in Biomedical Engineering, Life Sciences or Cell Biology/Immunology with 4 - 6 years of relevant experience, preferably in Cell Therapy and/or Apheresis Operations Technical Support


PE III - Skills/Knowledge Required:
  • B.S. or M.S. in Biomedical Engineering, Life Sciences or Cell Biology/Immunology with 6 - 8 years of relevant experience, preferably in Cell Therapy and/or Apheresis Operations Technical Support


Qualifications:
  • relevant GMP experience in a Manufacturing Environment/Commercial stage drug products or drug substances
  • Leadership and strategic thinking for collaborating in a matrix environment and developing best practices.
  • Experience with data trending and statistical tools.
  • Highly organized, detail oriented and flexibility to work with Apheresis site schedules.
  • Established track record of success with sound technical mindset, sense of urgency, troubleshooting and problem-solving skills.
  • Ability to assess risk and develop contingency plans for continuous improvements.
  • Excellent communication, writing, organizational, teamwork, and presentation skills.
  • Strong interpersonal and leadership skills to work with teams across different functions and organizations.


Additional Skills:
  • Experience with Apheresis equipment and operations.
  • Lean/ Six Sigma experience is preferred.
  • 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 science and compliance and strong environmental, health, and safety performance.
  • Have a mindset of continuous improvement, problem solving, and error prevention.


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.