Principal Scientist - BioProcess Development

Principal Scientist – Bio Process Development

San Diego, CA, USA (92121)

The Principal Scientist, Bio Process Development is a senior technical leadership role responsible for the design, development, optimization, and scale‑up of bioprocesses for plasmid DNA, protein biologics, and emerging modalities. This position serves as a scientific authority and technical project lead, bridging hands‑on process development with strategic program execution. The Principal Scientist independently leads complex development programs, drives platform and technology innovation, and ensures successful technology transfer to Manufacturing and MSAT.

• Lead complex upstream/downstream bioprocess development programs. Act as technical escalation point for complex process, scale up, and manufacturability challenges across development programs.
• Serve as technical project lead and define development strategies aligned with client requirements and timelines, regulatory phase, and manufacturing constraints. Ensure development activities comply with EHS, quality, and data integrity requirements.
• Design scalable processes using QbD principles. Evaluate and implement new technologies, materials, and unit operations to improve yield, robustness, and cost of goods. Drive process characterization, process definition, and comparability studies in support of process changes or scale transitions.
• Author and review development protocols, SOPs, reports, technical documentation, and tech transfer documentation. Support technical presentations/publications.
• Coordinate tech transfer with Manufacturing, QC, and MSAT. Review and provide critical input to batch records, development protocols, and technical instructions supporting GMP execution. Partner with MSAT and Manufacturing to support process validation readiness and late stage development activities, as needed. Support root cause investigations and CAPA development for process related deviations impacting development or manufacturing.
• Support RFPs and customer technical discussions. Support client onboarding and technical due diligence, including assessment of incoming processes and data packages.
• Provide technical mentorship. Contribute to technical governance forums, development reviews, or internal scientific committees.
• Provide scientific input to cost modeling, process economics, and capacity planning discussions. Represent Process Development in cross‑functional decision making related to program strategy, timelines, and risk.
• Contribute to platform and continuous improvement initiatives. Champion standardization, platform processes, and best practices while maintaining flexibility for client‑specific needs.

• Bachelor of Science degree in Biochemistry, Biological Sciences, Bioengineering, Chemistry, or related scientific discipline;
  Master’s Degree or PhD in Biology, Chemistry, Engineering or related scientific field is preferred.
• Minimum 10 years of relevant experience with 5 years in Contract Development and Manufacturing services of Biopharmaceuticals.
• Experience in plasmid and protein development and/or manufacturing is required. Additional experience in RNA or LNP is preferred.
• Ability to travel up to 10 %.
• Experience in biotherapeutic process development and manufacturing; proven track record of independent decision making on complex technical issues with appropriate risk assessment and escalation.
• In‑depth knowledge in upstream fermentation process development and downstream purification development to support pipeline projects, platforms, and innovative technologies.
• Strong analytical skills with experience in process mapping and design.
• Proficiency in data analysis and performance measurement tools.
• Demonstrated ability to operate effectively in a client‑facing CDMO environment, balancing scientific rigor, timelines, and customer expectations. Ability to clearly communicate complex technical concepts to diverse audiences, including non‑technical stakeholders and clients.
• Extensive experience as a project lead for biologics pipeline programs. Strong capability in managing evolving timelines, program risks and mitigation strategies. Strong…