Senior Specialist, SUS Process Engineer II - Cell Therapy - Washington, Seattle

Senior Specialist, SUS Process Engineer II - Cell TherapyPermanent

Washington, Seattle - 98127
  • Applications 0
  • Post Date: 2022-10-22
  • Views 51
  • Job Categories:Engineering
  • Job Type:Permanent
  • Published Date:2022-10-22
  • Salary Period:Annual
  • Company Name:Bristol Myers Squibb
  • Company Type:Agency

Job Simplification

The announced job offer is made public by the firm: Bristol Myers Squibb and it was included in jobs list the date of: 2022-10-22 in the website greenenergyjobsonline.com.

It is announced that they have a job offer at the category of Engineering and the jobs location is in the state of Washington at the city Seattle, in the country US - at this current ZipCode: 98127

The information residing in this page is not directly announced by our websites, we help users in the intent of finding the jobs they want and redirect them back to jobs8 for apropriate applying to any of the jobs listed on www.greenenergyjobsonline.com.

Job Overview

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 body's immune system to treat cancer.

We are looking for a Senior Specialist, Single Use System (SUS) Process Engineer II to join the Raw Material (RM) Team within the Cell Therapy GMSAT (Global Manufacturing Science and Technology) department. The successful candidate will collaborate with the GMSAT teams in the USA (Seattle, New Jersey and Devens) and in Europe (Leiden) for efforts related to SUS and RM. They will be also supporting Contact Manufacturing Organizations (CMO) located in the different markets. The Senior Specialist, SUS Process Engineer II will be responsible for working with cross-departmental teams, planning/executing risk assessments, building strategy for comparability exercises to enable change implementation, and deviation management.

This role is responsible for creating supporting/leading vendor change notifications, supporting dual sourcing strategies, proactive process monitoring using statistics, supplier change notification (SCN), and leading investigations. This role will also be responsible for supporting and developing designs and implementation of SUS and RM best practices and new designs.

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

  • Collaborate with process engineers and analytical scientists by applying SUS knowledge to support CAR-T and viral vector manufacturing process teams.
  • Development of criteria for risk assessment and execution of process risk assessments.
  • Support regulatory filings.
  • Lead technical discussions with suppliers for investigations and improvements
  • Assess SCN for potential impact on process performance and product quality.
  • Lead efforts focusing on alignment and harmonization of implementation strategies across sites.
  • Leverage and maintain strong relationships across multiple sites and vendors.
  • Coach/support junior staff on the team on complex technical issues
  • Up to 10% travel may be required domestically (primary) and internationally (potentially)

Skills/Knowledge Required :

  • B.S. with 3+ years or M.S. with 1-2 years relevant experience in Biochemical, Chemical, Biomedical, Material Science Engineering or Cell Biology/Immunology discipline or equivalent with 1-2 years of relevant experience in managing SUS projects.
  • Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects working in a self-driven, performance/results oriented, fast paced matrix environment.
  • Experience or familiar with development and/or characterization of vaccines, biologics and/or cell therapy manufacturing processes.
  • Demonstrated ability to understand mechanical and chemical properties of polymers
  • Experience working in a GMP environment. Understanding of compendial requirements and how to assess specifications. Familiarity with ICH guidelines.
  • Experience working with vendors and contract manufacturing sites is preferred
  • Excellent problem-solving skills, including issue resolution, root cause investigations and CAPAs. Ability to assess risk and develop contingency plans for mitigation.
  • Detail oriented with excellent verbal and written communication skills. Strong scientific and technical writing skills. Able to manage time and elevate relevant issues to project lead and line management.
  • Proficiency utilizing MS Office products and statistical software (R, JMP, Minitab)

Additional Skills:

  • Single Use (SU) component experience is strongly preferred.
  • Familiarity with cell therapy, experience with cellular therapies is preferred.

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 to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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

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Employer Overview

Bristol Myers Squibb

Washington, Seattle - 98127
  • Agency