Quality Control Scientist Cell Therapy Bioanalytic

Profile

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.

The QC Scientist is responsible for supporting Quality Control bioanalytical testing for release of clinical and development products. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. Additionally, when needed, this position will be able to assist with training and assay transfer.


Required Competencies: Knowledge, Skills, and Abilities
Advanced hands-on experience with various analytical techniques including but not limited to ELISA, qPCR, FACS and scientific knowledge in the characterization and transfer of pharmaceutical products.
Advanced ability to accurately and completely understand, follow, interpret and apply Health authority Regulatory and cGMP requirements .
Advanced technical writing skill s .
Advanced problem - solving ability/mentality, technically adept and logical.
Ability to represent the interests of the gro u p on cross - functional team s .
Ability to set priorities of the group and manage timelines.
Advanced a bi lit y to communicate effectively with peers, department management and cros s -functional peer s .
Duties and Responsibilities
Perform testing of in-process, final product, and stability samples.
Utilize scientific principles to assist in analy tical testing methods and the proper use of laborato r y equipment.
Capable of handling complex issues and solving problems with only general guidance.
Prepare and present continuous improvement projects to management.
Comprehensive understanding of regulatory guidelines and can independently develop, write and execute methods, protocols, reports and other related documents.
Complete all work in a timely manner.
Perform peer review of testing data.
Review all data in accordance with applicable procedures and cGMP requirements.
Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
Complete all reviews in accordance with required release timelines.
Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required.
Train new analysts to general job duties.
Complete necessary training to become a qualified trainer.
Perform training effectively.
Document training per procedural and cGMP requirements.
Support document revision, project, CAPA, and investigation/deviation tasks.
Perform assigned tasks within a CAPA, deviation, or project
Participate in complex projects and continuous improvement efforts.
Take a leadership role, as required, for projects.
Draft and review technical documents, such as SOPs and protocols/reports.
Communicate effectively with management regarding task completion, roadblocks, and needs.
Demonstrate initiative, courage, and continuous improvement throughout investigation/corrective action lifecycles.
Performs other tasks as a s signed.
Education and Experience
Bachelor's degree required, preferably in Science.
Advanced Degree preferred.
5-8 ye ars o f relevant work experience, preferably in a regulated environment.
An equivalent combination of education and experience may substitut e.
Working Conditions
The incumbent should be able to distinguish colors and possess correctable vision to 20/20, annual eye exam is required.
The incumbent must analyze numerical values on a daily basis.
The incumbent will be working a laboratory setting, up to six ( 6) hours per day.
The incumbent will be working around bio hazardous materials, including chemical agents up to six ( 6) hours per day.


This job description is intended to describe the general nature and level of work being performed b y th e perso n assigne d t o thi s position . Th e primar y duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or seconda r y to the overall purpose of this job. Employees holding this position will be required to perform any other job - related duties as requested by management.

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.

Company: Bristol-Myers Squibb

Req Number: R1521396_EN

Updated: 2020-03-05 00:00:00.000 UTC

Location: Warren,New Jersey

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.

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