Associate Specialist Vector Operations

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 Vector Operations Associate Specialist, will be part of 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/vector testing and external manufacturing. The Scientist will work collaboratively with teammates in Quality, Manufacturing, Supply Chain, and Contract Testing Organizations (CTLs).

Job Summary

The primary focus of the role will be to support all cell therapy QC testing programs from clinical development through commercialization by providing quality oversight of sample plans, sample management and tracking, generation of GMP documents such as Certificates of Analysis, and Certificates of Testing and LIMS support. This includes test articles for plasmids, vectors, drug product intermediates, and drug products. This position will provide additional support of contract manufacturing organizations (CMO) and contract testing laboratory (CLT) virtual plant teams.

Primary Responsibilities


Develop and manage sample plans

Manage and track test samples and test results from contract manufactures and contract test labs

Manage incoming CofAs and CofTs and create internal COAs as necessary

Serve as the primary contact for the vector QC LIMS development team.

Enter test results into LIMS and generate reports and COAs as needed

Provide support for QC, cell bank, plasmid, vector, and drug product teams.





Support stability testing for Global Product Quality across teams and processes.

May support regulatory submissions and responses to questions from healthy authorities

Support GPQ operations by:

Managing change controls, deviations, OOS results, and investigations in QC owned records through document and/or quality management system(s) globally.

Manage Product Specifications (upstream plasmids, cell banks, vector, DP intermediates, and DP) where appropriate.

Support other early development and late development / commercial vector related activities as needed.

Other duties as assigned


Basic Qualifications:


5 years industry related experience

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 products, or plasmid vaccines.

Ability to work independently 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:


Experience with cell therapy programs in an analytical, process, and/or regulatory submission capacity

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

Experience with eQMS, Veeva (document management system), and general Quality systems

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


Education Requirements:


BS in relevant scientific discipline and 6 years’ experience in analytical methods, contract manufacturing and testing, QC, or equivalent combination of education and experience.


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

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