$100K — $150K *
The Manager of advanced therapy medicinal products (ATMP) Viral Safety is a driven subject matter specialist and leader in the laboratory, supporting multiple areas of the organization. These areas include MAb and ATMP Manufacturing, Process Sciences (PS) and Quality Control (QC). We are looking for someone who can actively guide each area through the insurance of viral safety for advanced therapy medicinal products (ATMPs) at IOPS.
As the Manager of ATMP Viral Safety, a typical day might include the following:
- Guiding and coordinating the Viral Safety Program as an expert for viral clearance validation review at IOPS as well as manufacturing investigations of upstream and downstream processing
- Improving the tripod PREVENT-DETECT-RESPOND to viral contamination for both MAbs and ATMPs
- Developing holistic understanding and IOPS strategy for the best viral safety and control practice while performing training with QA and EHS
- Executing and supervising viral safety project management to contribute to the response/filing of Regulatory information requests
- Reviewing pertinent Regulatory dossier sections by writing GMP documentation
- Conducting viral safety risk assessment for ATMPs manufacturing and QC lab practices (assay development, transfer and testing i.e. cell and molecular based assays, automation, rapid micro and Next Generation Sequencing +bioinformatics)
This role might be for you if:
- You demonstrate proven technical writing skills
- You are a strong communicator and work well with others
- You can work across the entire enterprise effectively while maintaining flexibility
To be considered for this role a PhD in Life Sciences, or a related field, is preferred but not required with 7+ years of proven experience. Experience in the biotechnology industry (process sciences, virology, molecular biology or virology, biochemistry, gene therapy) is preferred. Previous supervisory experience is required. We need someone who will continuously strive to improve processes to then improve performance.
Valid through: 4/21/2021