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Job Details


Bristol-Meyers Squibb, Co.

Senior Specialist, Raw Material & SUS Process Engineer II (R1557051-en-us-1)

Pharmaceuticals

All

Yearly

No

Seattle, Washington, United States

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.

Job Purpose / Position Summary

BMS is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture. 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 bodys immune system to treat cancer.

We are looking for a Raw Material (RM)/Single Use System (SUS) Process Engineer I/II to join the raw materials team within the Cell Therapy GMSAT (Global Manufacturing Science and Technology) department. The Raw Materials team is responsible for management of end to end raw materials including buffers, reagents, media as well as critical single use equipment and product contact equipment. This includes but not limited to vendor management, change control partnership with the vendors, proactive process monitoring using statistics, deviation management, process improvements to support CAR-T therapies during late stage clinical, tech transfer, and commercial production.

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

  • Vendor management including change controls, audits, deviations, and Quality Risk Management programs.
  • Collaborate with raw materials development team for standards, best practices and early engagement.
  • Lead qualifications of materials, development and setting of specifications.
  • Support production related investigations, ensuring compliance with internal standards and regulatory requirements.
  • Provide necessary technical analysis to support impact assessments and investigations.
  • Share operational and process leanings with the rest of the manufacturing network.
  • Support authoring of responses for Information Request (IR) from regulatory bodies.

Basic Qualifications:

  • B.S. with 2-4 years or M.S. with 1-2 years relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline or equivalent with 2 years of relevant experience in raw materials for cell/gene therapy, biologics or vaccines.
  • Experience with raw materials (liquids and single use) is preferred. Familiarity with cell therapy processes and cGMPs is strongly preferred.
  • Understanding of compendial requirements and knowledge on how to assess specifications.
  • Experience working with vendors and contract manufacturing sites is preferred.
  • Experience working in a self-driven, performance/result 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.
  • Ability to effectively work in cross functional teams, meet deadlines, and prioritize responsibilities.
  • 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.
  • Proficiency utilizing MS Office products.
  • Working knowledge or understanding of statistical software (R, JMP, Minitab).
  • Experience with commercial product support, i.e. post-marketing commitments.
  • Lean Manufacturing experience is desired.

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.

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 . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.