Job Details

Senior Specialist, Process Engineer II - Cell Therapy Product Steward

Drug Dev and Preclinical Studies

icon-location-marker Seattle - WA - US
icon-location-marker Summit West - NJ - US
Posted 47 days ago Full_time R1537547

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.

We are looking for a Process Engineer to join the drug product team within the Cell Therapy GMSAT (Global Manufacturing Science and Technology) department.

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 Senior Specialist, Process Engineer II - Cell Therapy Product Steward will be responsible for the implementation of cell therapy manufacturing technologies, including cross-departmental collaboration to enable facility fit, development of process documentation (Batch Records, Forms, etc), e-systems deployment, inspection readiness, and training. The Process Engineer II will support product lifecycle management, including commercialization and evolution of cell therapy products as well as day to day operations to ensure reliable quality supply.  The role collaborates across all CMC functional areas to ensure project advancement, rapid and best in class execution, and communication of challenges/opportunities.

Responsibilities include, but are not limited to, the following:

  • Support process and technology transfers, change management, and technical process support for cell therapy products.
  • Implement and support the creation and execution of process control strategies including process risk assessments and continued process verification.
  • Support production related investigations, ensuring compliance with internal standards and regulatory requirements.
  • Perform monitoring of manufacturing processes to understand process capability.
  • Provide necessary technical analysis to support impact assessments and investigations.
  • Develop, execute and implement manufacturing process improvement activities in accordance with the overall life cycle plan for the product
  • Share operational and process leanings with the rest of the manufacturing network

Basic Qualifications:

  • MSc or BSc in Chemical Engineering, Biochemical Engineering or equivalent with minimum of 3+ years of relevant experience. Familiarity with cell therapy processes and cGMPs is preferred.
  • 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, including issue resolution, root cause investigations and CAPAs.
  • Ability to assess risk and develop contingency plans for process risks
  • Able to manage time and elevate relevant issues to project lead and line management.
  • Detail oriented with excellent verbal and written communication skills.
  • Strong interpersonal and leadership skills to work with teams in different functions and organizations

Preferred Qualifications:

  • Experience with cell therapy process development and / or manufacturing
  • Experience with technology transfer in a manufacturing environment
  • Proficiency utilizing MS Office products and working knowledge of statistical software (R, JMP, Minitab)
  • 2-3 years of experience in cell therapy process development and/or manufacturing.
  • Experience with commercial product support, i.e. post-marketing commitments, on-going validation and comparability

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

VETERAN

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. 

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.  Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.  This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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