Title: Quality Control Associate Director, Pre-Commercial
Summary:
My client is a market leader in the biotechnology sector with a dynamic, well-resourced, and creative pipeline in the oncology sector. Their colleagues have substantial histories in clinical research and regulatory affairs, are recognized leaders in the analytical and process sciences, and have proven commercial and marketing abilities. They have two products now available, and a promising pipeline for gene therapy.
Our client is seeking a highly motivated and knowledgeable QC professional to oversee the technical direction of their clinical programs and be directly responsible for the QC deliverables and strategies that underpin product development activities. Reports directly to the Chief of Quality Control.
Responsibilities and Functions:
Creates product-specific QC release and stability test procedures, as well as method controls.
Coordinates and directs activities at contract testing laboratories (CTLs) involving methodologies for development/optimization, validation, and transfer.
Provides a technical analysis of stability data.
Creates product-specific QC release and stability test procedures, as well as method controls.
Supports QC routine operations by establishing and implementing processes that allow for successful collaboration with business partners to achieve efficient and high-quality outputs.
Qualifications and Experience:
BS in Chemistry, Biology, Biochemistry, or a relevant technical degree; PhD or MS encouraged.
Must have experience in BLA authoring, Validation, Batch Release, and sterilization
QC or analytical development for biopharmaceutical goods, with a minimum of 10 years direct experience and exposure to all phases of product development.
A proven track record of handling CRO management, qualification, and transfer efforts, and directing and overseeing the development of analytical procedures.
Ability to travel domestically and internationally up to 15%
Benefits:
Hybrid work is available
Remote working is available
Medical, Dental, Vision, and 401K matching
