We are seeking a highly motivated and experienced Principal Scientist to drive conjugation process development activities supporting bioconjugates, including antibody-drug conjugates (ADCs), oligonucleotide conjugates (AOCs, ARCs, etc.), and other conjugate therapeutics. This individual will serve as a technical leader responsible for developing robust, scalable, and phase-appropriate conjugation processes from early development through commercial readiness.
The successful candidate will provide scientific leadership across process chemistry, analytical characterization, technology transfer, manufacturing support, and regulatory documentation while collaborating closely with CMC, analytical, manufacturing, quality, and project management teams.
Responsibilities- 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.Qu
Required Qualifications- Ph.D. in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related scientific discipline with 10+ years of relevant industry experience; or M.S. with 12+ years of 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.
Preferred Qualifications- Experience with site-specific conjugation technologies and next-generation ADC platforms.
- Familiarity with high-potency compound handling and containment operations.
- Experience presenting development findings externally to client sponsors.
- Knowledge of analytical methods including HIC, SEC, LC-MS, CE-SDS, and DAR characterization.
- Prior experience supporting late-stage or commercial process validation activities.
FLSA: Exempt
