Senior Stability Specialist Global Product Quality 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.

The Senior Stability Scientist, Global Product Quality will bea memberof the Global Product Quality (GPQ) Department. GPQ supports the development and commercialization of cell therapy products through representation on virtual plant teams, oversight of product testing and external manufacturing. The QC Senior Stability Specialist will work collaboratively with teammates in Quality, Manufacturing, Supply Chain, and the project teams that have external manufacturing needs.

Job Summary

The primary focus of the role will be to support all cell therapy stability programs from clinical development through commercialization by providing quality oversight and management of cell banks, plasmids, vectors, drug product intermediates, drug products and drug product specifications. May provide additional support of contract manufacturing organizations (CMO) virtual plant teams.

Primary Responsibilities

Support staff for QC program representative for cell bank, plasmid, vector, and drug product teams.

Support stability strategy and implementation for Global Product Quality across teams and processes.

May support regulatory submissions and response to questions from healthy authorities

Support operations functions associated with:

Manage change controls and QC owned records through document and/or quality management system(s). Process Specifications.

Specification management (upstream, vector, DP intermediates, and DP), change control ownership and implementation globally

Will support all early development and late development / commercial activities as needed.

Other duties as assigned

Basic Qualifications :

6 years of Quality related experience in a GMP manufacturing setting with a strong focus on conducting Investigations.

Strong writing skills are essential as this role will be involved with authoring Investigation Reports.

Scientific background in analytical methods and stability

Understanding of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of biological, cell therapy, or small molecule products.

Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects.

Strong written, verbal, and organizational skills, and ability to work in inter-disciplinary and cross-functional teams.

Strong attention to detail and organization skills.

Preferred Qualification:

Background in plasmid manufacturing, mammalian cell banking, DNA cloning, DNA sequencing methods, or cell therapy.

Experience with eQMS, CellDox, and general Quality systems

Experience working with external suppliers: CMOs/CROs/CTLs/CSPs

Education Requirements:

Bachelor's Degree in a relevant scientific discipline

Primary Work Location:

Summit, NJ or Seattle, WA

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: R1521686_EN

Updated: 2020-02-24 00:00:00.000 UTC

Location: Seattle,Washington

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.

Company info

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