Quality Control Molecular Scientist 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.

PURPOSE AND SCOPE OF POSITION:

The Scientist is responsible for supporting Quality Control bioanalytical testing for release of clinical and commercial 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 development, validation & transfer.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:


Advanced hands on experience with various analytical techniques including 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 Global Regulatory and cGMP requirements.

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 team members, 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 in the pharmaceutical industry is required.

Knowledge of GMP Regulations required.

Experience working in an Aseptic Manufacturing environment is highly preferred.

An equivalent combination of education and experience may substitute.

Ability to work extended hours, occasional weekends and holidays


DUTIES AND RESPONSIBILITIES:

Perform testing of in-process, final product, and stability samples.


Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory 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 and focus on Right First Time (RFT).


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 collaborative teamwork, with regards to review of results.


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.



Complete assigned tasks within a CAPA, deviation, or project on time

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.

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.

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