We are seeking an experienced Senior Scientist with a broad technical background in Biologics and ADC Analytical Development and characterization to join our Manufacturing Sciences and Technology (MS&T) team. This position will have a dual role in the company and a wide range of input to support product development and cGMP manufacturing. Initially the position will be external facing and be the AD SME driving technical discussions with External CMOs as we drive multiple antibody and ADC candidates to IND. Later, and as dictated by company needs, the incumbent will work to establish in-house AD capabilities as part of a broader MST team.
For our currently outsourced development candidates, the incumbent will partner with our internal team and the CMO analytical and QC teams for the development, qualification, and validation of key assays. The scientist will participate in investigations and troubleshooting and drive documentation such as SOPs, development, qualification and validation report. The ideal candidate will make detailed observations, analyze data, interpret results, and exercise appropriate technical judgment in the design, management, and interpretation of experiments. The incumbent will generate critical documentation to support quality sections of multiple INDs.
- Have broad knowledge in separation sciences for quality assessments of in-process, intermediates, and drug substance/drug products.
- Be able to interpret all in-process testing data and provide insight to team members regarding process development and controls.
- Skillfully assemble technical documentation and data, drive SOP generation, develop and finalize development report and assay qualification/validation report.
- Provide oversight to tech transfer to Quality Control at the CMOs
- Thoroughly analyze and review data and provide summary to manager.
- Be keen on Troubleshooting assays.
- Have a good knowledge of ICH principles.
- Ph.D. in biological science or biochemistry with 5+ years in Biotech development setting
- A thorough understanding of separations and characterization technologies and instrumentation in protein analysis is required.
- Ability to critically analyze data using statistical tools and to compile technical reports.
- Ability to influence cross-functionally in a matrix environment.
- Strong oral and written communication skills; experience with GMP operations, technical reports, and specifications
Please send resume to firstname.lastname@example.org