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QC Specialist Global Product Quality

Employer
Bristol Myers Squibb Company
Location
Celgene, NJ, United States
Start date
Sep 4, 2020

View more

Discipline
Clinical, Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

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).

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 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.

Company

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

At Bristol Myers Squibb, we believe in the power of science to address some of the most challenging diseases of our time. Our focus on these unmet needs comes during a remarkable time, when unprecedented scientific breakthroughs are advancing the treatment of disease as never before in human history.

We work every day to transform patients’ lives through science. Each day, our employees around the world work together for patients – they are at the center of everything we do. They inspire us. They are the reason we come to work each day.

We combine the agility of a biotech with the reach and resources of an established pharmaceutical company to create a global leading biopharma company powered by talented individuals who drive scientific innovation.

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Company info
Website
Phone
+1-800-332-2056
Location
430 E. 29th St
14th Floor
New York
New York
10016
United States

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