Position OverviewWe are seeking an experienced and motivated Senior/Principal Scientist in ADC Conjugation Process Development to support our growing pipeline. This role will be responsible for the optimization of critical conjugation and purification process parameters for ADC Drug Substance (DS) Development. The preferred candidate will coordinate and execute strategies from milligram to multi-gram scales, including tox/GMP batches, while demonstrating practical expertise in different methodologies and purification strategies for clinical and commercial-stage ADC DS manufacturing. The ideal candidate will have experience with technology transfer, regulatory compliance, and coordination with CDMO partners at GMP manufacturing facilities. A strong working knowledge of different conjugation technologies and cytotoxic linker-payloads is essential, as is experience with standard analytical and characterization approaches used for both biologics and ADCs.
Responsibilities- Implement and execute ADC Conjugation Process Development (PD) strategies, including Design of Experiment (DOE) and One Factor at a Time (OFAT) approaches for critical reaction parameters.
- Oversee the progression of ADC batch sizes from milligram to >100 g scales to support not only PD optimization, but analytical and formulation development, DS/DP stability studies, and in vivo experiments (including critical GLP tox studies) for both IND- and BLA-stage activities.
- Lead the multi-gram scale purification optimization for both antibody intermediates and ADCs via ultrafiltration/diafiltration (UF/DF), and, if required, preparative chromatography or other approaches.
- Fulfill role as ADC DS subject matter expert (SME) on both internal cross-functional CMC teams and for external CDMO partners to ensure alignment on ADC program goals, deliverables, and objectives. Occasional travel to advise and oversee Development and GMP manufacturing processes will be expected.
- Prepare essential documentation (SOPs, protocols, and reports) to support tech transfers, GMP activities, and regulatory submissions for clinical development and commercialization.
- Stay current with emerging trends, innovations, and regulatory requirements for ADC DS, integrating necessary or potentially beneficial features into our internal company strategies and workflows.
- Lead/support authoring and reviewing of relevant module 3 sections of regulatory submissions (IND, IMPD, BLA, etc.), along with, if necessary, responding to information requests and interfacing with global health authorities.
Qualifications- A Bachelors, Masters, or Ph.D. degree in Chemistry, Chemical/Biochemical Engineering, Biotechnology, or a related field.
- A minimum of 5 years of biotech/biopharma industry experience with a Ph.D., 8 years with a Master's, or 10 years with a Bachelor's degree. An ADC or Conjugation/Bioconjugation Process Development focus is required.
- Demonstrated success with the development and scale-up of different ADC conjugation technologies and strategies, including a proven ability to work with a variety of different small molecule linker-payloads and antibody intermediate materials. Expected expertise in relevant laboratory operations and equipment necessary for successful execution of development activities.
- Prior experience with tech transfer, external CDMO engagement (encompassing both Development and GMP manufacturing activities), and internal coordination with relevant cross-functional teams.
Knowledge and Skills- A strong understanding of the common conjugation, purification, analytical, and characterization approaches used for ADCs, with a solid foundation in overcoming some of the challenges encountered in these workflows.
- Expertise in tangential flow filtration (TFF) at the multi-gram scale for the efficient removal of unreacted linker-payloads and to provide a stable ADC DS formulation.
- Good working knowledge of standard analytical and characterization techniques used for ADCs including, but not limited to, SEC, HIC, and RP U/HPLC chromatographic methods in addition to LC-MS, icIEF, and CE-SDS strategies for biomolecules and related conjugates.
- Knowledge of GMP standards and regulatory guidelines, with experience supporting IND, INDa, and BLA submissions.
- The ability to manage multiple projects simultaneously while being able to prioritize and balance hands-on tasks with strategic responsibilities.
- Exceptional communication skills, with an emphasis on effective collaborations with both internal stakeholders and external partners.
Washington State Pay Range
$146,000-$188,000 USD
