Full Job Description
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
The Vector Operations QC 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 QC Specialist will work collaboratively with teammates in Quality, Manufacturing, Supply Chain, and Contract Testing Organizations (CTLs).
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.
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.
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
BS in relevant scientific discipline and 5+ years' experience with analytical methods, contract manufacturing and testing, QC, or equivalent combination of education and experience.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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 with the resources to pursue their goals, both at work and in their personal lives.