Bristol Myers Squibb Company

Associate Scientist, Raw Materials

Seattle, WA, United States
Sep 04, 2020
Required Education
Bachelors Degree
Position Type
Full time
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.

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.

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.

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 Science.
  • 5-8 years of relevant work experience, preferably in a regulated environment.
  • An equivalent combination of education and experience may substitute.

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.