Assistant Scientist, Clinical QC Microbiology

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us.

Title: Assistant Scientist, Clinical QC Microbiology

Location: Warren, NJ

The Assistant Scientist, Development QC role is responsible as single point of contact for all deviations, OOS, CAPA and training management. Additional responsibilities include, assisting in technical transfer activities from research to clinical QC and managing the general operation, workflow of the QC function. The candidate’s responsibilities include, but are not limit to, creating technical protocols, reports, SOPs, risk assessments, and specifications.

Qualifications & Experience:

• Bachelor’s Degree required, preferably in Science.
• Advanced Degree preferred.
• 5-8 years of relevant work experience, preferably in a regulated environment.
• An equivalent combination of education and experience may substitute.

• Advanced experience and knowledge of Compendial methods and requirements such as United States Pharmacopoeia (USP), European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP)
• Minimum of 5 years of QC experience or related GMP laboratory experience in the pharmaceutical industry.
• Advanced ability to accurately and completely understand, follow, interpret, apply Global.
• Advanced knowledge if investigation writing, CAPA and deviation management.
• Knowledge of Sample Management and QC operations in a cGMP regulated environment.
• Advanced knowledge of risk management and the proven ability to apply the concepts of risk management effectively.
• Familiar with various analytical techniques including but not limited to: ELISA, qPCR, Flow Cytometry and scientific knowledge in the cell therapy product release field.
• 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.

Key Responsibilities:

• Responsible for managing Development Operations QC Quality System records in compliance with company guidelines.
• Ensures control of systems, processes and product through supporting the maintenance of a Quality System.
• Ensures QC procedures and processes are maintained, adequate and efficient.
• Leads and coordinates QC 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.
• Responsible for assisting in Development Operations QC sample management programs.
• Collaborates with the QC Sample M