Quality Control Scientist Incoming Cell Therapy

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.

Responsibilities:

Perform testing of in-coming raw materials and consumables.

Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.

Perform samplings and visual inspections in warehouse settings with different temperature zonings.

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.

Manage shipment of samples for tests performed at contract testing laboratories.

Review data and results generated at contract testing laboratories.

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 assigned.

Required Knowledge/Skills:

Experience and knowledge of Compendia methods and requirements such as United States Pharmacopoeia (USP), European Pharmacopoeia (EP) and Japanese Pharmacopoeia (JP)Advanced ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements

Knowledge of AQL/ANSI Standards

Hands on experience with various analytical techniques and scientific knowledge in, but not limited to, HPLC, GC, FTIR, Osmolarity and pH

Ability to accurately and completely understand, follow, interpret and apply Global Regulatory, cGMP requirements and ISO requirement for devices

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 set priorities of the group and manage timelines.

Ability to work with management locally and globally.

Advanced ability to communicate effectively with peers, department management and cross- functional peers.

Education and Experience:

Bachelor’s Degree required, preferably in Science.

Advanced Degree preferred.

5-8 years of relevant Quality Control work experience, preferably in an Aseptic (Biologics or Cell Therapy) environment.

An equivalent combination of education and experience may substitute.

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 biohazardous materials, including chemical agents up to six (6) hours per day.

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.

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, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com