Sr Principal Scientist, Conjugation Process Development
On-site · Bristol, Pennsylvania, United States
Job Summary
Lead development and optimization of conjugation chemistry processes for bioconjugates, including ADCs and other linker-payload platforms. Design scalable and manufacturable conjugation strategies with a focus on process robustness, product quality, yield, and reproducibility. Develop and execute DOE campaigns, and scale-up strategies for clinical manufacturing. Serve as subject matter expert (SME) for conjugation chemistry, analytical characterization of conjugation processes, and process controls. Collaborate with analytical development teams to establish critical quality attributes (CQAs), in-process controls, and release specifications. Author and review technical reports, development summaries, batch records, SOPs, regulatory sections (IND/BLA/IMPD), and technology transfer documentation. Provide technical oversight during CGMP manufacturing campaigns as needed. Troubleshoot process deviations, investigations, and manufacturing challenges related to conjugation operations. Drive implementation of platform technologies and continuous improvement initiatives to enhance process efficiency and scalability. Mentor junior scientists and contribute to scientific strategy, innovation initiatives, and cross-functional technical leadership. Present development updates and technical recommendations to senior leadership and client project teams.
Required Qualifications
- Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related scientific discipline with 10+ years of relevant industry experience
- Extensive experience in bioconjugation process development, particularly ADCs or related targeted therapeutics
- Strong understanding of conjugation chemistries, linker-payload technologies, purification methods, and protein/conjugate characterization
- Demonstrated experience supporting CGMP manufacturing and technology transfer activities
- Working knowledge of CMC development principles, regulatory expectations, and phase-appropriate development strategies
- Experience with statistical experimental design (DOE) and process characterization methodologies
- Proven ability to independently lead complex technical programs in a fast-paced environment
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