Title: **REMOTE** Associate Director, Pre-Commercial, QC Role
Summary:
My client is a leader in the biotechnology industry who is a rapidly growing firm with an active, well-funded, and innovative pipeline in the Oncology field. Their colleagues are recognized leaders in the analytical and process sciences, have extensive backgrounds in clinical research and regulatory affairs, and have demonstrated commercial and marketing skills. They have two products on the market and exciting gene therapy pipeline.
Our client is looking for a highly driven and skilled QC specialist to guide the technical direction of their clinical programs and be directly accountable for the QC deliverables and strategies that support product development activities. This position reports directly to the head 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.
- Nice to have BLA Authoring, Validation, Batch Release, and sterilization
- Minimum of ten years direct experience in QC or analytical development for biopharmaceutical products, having exposure to all stages of product development.
- The preference is for someone who has prior experience working in a matrixed system.
- A proven track record of handling CRO management, qualification, and transfer efforts, and directing and overseeing the development of analytical procedures.
- Excellent written and communication skills, scientific report writing
- Strong computer skills
- Ability to travel domestically and internationally up to 15%
Benefits:
- Hybrid work is available
- Remote working is available
- Medical, Dental, Vision, and 401K matching
