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Associate Scientist, Raw Materials - Cell Therapy

Company: Bristol-Myers Squibb
Location: Seattle
Posted on: May 15, 2022

Job Description:

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. Purpose and Scope of Position: The Associate Scientist, Raw Material role is responsible as single point of contact for all deviations, OOS, CAPA and training management for the Raw Material team. The candidate's responsibilities include, but are not limit to, creating technical protocols, reports, SOPs, and risk assessments. Duties and Responsibilities:

  • Responsible for managing Development Operations Quality System records in compliance with company guidelines.
  • Ensures control of systems, processes and product through supporting the maintenance of a Quality System.
  • Ensures procedures and processes are maintained, adequate and efficient.
  • Leads and coordinates team member reviews of protocols and procedures.
  • Ensures deviations, CAPAs and Change controls are handled appropriately and in a timely manner. Initiates and/or implement changes in controlled documents.
  • Designs and/or implements and sustains Lean lab initiatives such as 5S, deviation reduction, right first time, permanent inspection readiness, visual management.
  • Provides oversight to risk management activities using FMEA.
  • Author SOPs, assay qualification, protocol, report and transfer and gap analysis reports.
  • Identify opportunities to improve technical and operational systems, practices, and technologies.
  • Comprehensive understanding of guidelines and can independently develop, write and execute method, protocols, reports, and other related documents. Education and Experience:
    • Bachelor's Degree required, preferably in a scientific discipline.
    • 4-6 years of relevant work experience, preferably in a regulated environment.
    • An equivalent combination of education and experience may substitute. Required Competencies: Knowledge, Skills, and Abilities:
      • Minimum of 3 years of QC experience or related GMP laboratory experience in the pharmaceutical industry.
      • Advanced ability to accurately and completely understand, follow, interpret, apply Global
      • Regulatory and cGMP requirements.
      • Advanced knowledge if investigation writing, CAPA and deviation management.
      • Able to perform responsibilities independently with minimal management oversight.
      • Advanced technical writing skills.
      • Advanced problem-solving ability/mentality, technically adept and logical.
      • Ability to represent the interests of the group on cross-functional teams.
      • Ability to work with management locally and globally.
      • Advanced ability to communicate effectively with peers, department management and cross- functional peers. 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 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. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Keywords: Bristol-Myers Squibb, Seattle , Associate Scientist, Raw Materials - Cell Therapy, Healthcare , Seattle, Washington

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