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    Senior Process Engineer, Cell Therapy Manufacturing, Science and Technology

    Bristol-Myers Squibb
    Seattle, WA 98101
    Full-time, Part-time
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    Job Description

    Senior Process Engineer, Cell Therapy Manufacturing, Science and Technology

    • Seattle, Washington, United States of America

    Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

    Join us and make a difference.We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.


    Cell Therapy Global Manufacturing Science and Technology (MSAT)

    Locations: Seattle WA or Summit, NJ


    Experience with tech transfer, manufacturing technical support, process development, GMP experience


    Celgene 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. Come and join Celgene for this key leadership role to be part of the team building a leading CAR T Platform that serves our patients with novel Celgene CAR T Therapies Our goal is to revolutionize medicine by re-engaging the body's immune system to treat cancer. 

    We are looking for a Senior Process Engineer to join the Comparability Team within the Cell Therapy GMSAT (Global Manufacturing Science and Technology) department. The successful candidate will collaborate with the GMSAT teams in Seattle and New Jersey locations in the US and support efforts related to tech transfer and lifecycle management. The Senior Process Engineer will be responsible for leading cross-departmental teams, and planning/executing risk assessments and strategy development for cell therapy analytical comparability exercises to enable change implementation.

    This role is responsible for developing study design and statistically derived criteria to evaluate pre-change and post-change results and summarize the strategy in technical protocols and results in technical reports. This person will collaborate across all CMC functional areas to insure project advancement, rapid and best in class execution, and communication of challenges/opportunities. The Senior Process Engineer will play a key role in product lifecycle management, including development, characterization, commercialization, and evolution of cell therapy products.

    The roles and responsibilities include, but are not limited to, the following:

    • Collaborate with process engineers and analytical scientists and guide comparability design by applying in-depth CAR-T manufacturing process knowledge
    • Perform statistical analysis of product attribute data as well as statistical tests and evaluation to assist the design and execution of comparability exercises for cell therapy products
    • Lead execution of process risk assessments, development of criteria justifications, and development of comparability protocols
    • Author and review regulatory filings summarizing the strategy and results from comparability exercises
    • Develop, understand, and manage tools and templates that can be used to quantify potential impact of changes on process performance and product quality
    • Contribute to alignment and harmonization of comparability strategies across multiple sites
    • Leverage and maintain strong relationships across multiple sites
    • Up to 10% travel may be required (primarily domestic travel)

    Basic Qualifications

    • B.S. or M.S. in Chemical Engineering, Biochemical Engineering or equivalent with 7-10 years relevant experience in biologic or cell therapy process/analytical development or commercial manufacturing process technical support
    • 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
    • Demonstrated ability to perform/document complex manufacturing processes and provide technical support in a clinical/commercial GMP environment
    • Experience in development and/or characterization of biologics and/or cell therapy manufacturing processes
    • 3+ years of experience working in a GMP environment, ICH guidelines, control strategy development, and working within a Quality organization
    • Excellent problem-solving skills
    • Proficiency utilizing MS Office products and statistical software (R, JMP, Minitab)
    • Able to creatively manage time and escalate relevant issues to project lead and line management
    • Strong scientific and technical writing
    • Detail oriented with excellent verbal and written communication skills

    Preferred Qualifications:

    • Preference given to candidates with experience writing regulatory submissions
    • Knowledge of cellular immunology a plus

    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 the resources to pursue their goals, both at work and in their personal lives.

    By fostering a culture of inclusion, we empower this 21st century workforce to achieve our company's mission of helping patients to prevail over serious diseases.

    Explore Job Opportunities

    A clear purpose. An inclusive culture. The chance to work at the top of your field. These are a few of the reasons Bristol Myers Squibb is the right choice for your next career move.

    Are you ready for a career where you make a profound difference? We invite you to visit us at one of our events to learn more.

    Bristol Myers Squibb endeavors to make this website accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.

    The Physician Payment Sunshine Act (Sunshine Act) requires Bristol Myers Squibb to report any transfers of value, including payments made to reimburse interview - related expenses, for candidates who are US - licensed physicians.U.S. licensed Physicians covered by the Sunshine Act include Doctors of Medicine, Osteopathy, Dentistry, Dental Surgery, Podiatry, Optometry and Chiropractic Medicine who are licensed to practice medicine in the U.S.This information will be reported to the Centers for Medicare and Medicaid Services(CMS) on an annual basis and CMS shall post submitted data on its public database.For more information, < a href = '' target = '_blank' > click here. < /a>

    Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.For our EEO Policy Statement, please < a href = '' target = '_blank' > click here < /a>. If you'd like more information on your EEO rights under the law, please click here: < a href = '' target = '_blank' > EEO is the LAW < /a> and < a href = '' target = '_blank' > Supplemental Information. < /a>

    Posting ID: 566858743Posted: 2020-08-08