Principal Scientist - BioProcess Development

Principal Scientist - Bio Process Development

Location:

San Diego, CA, USA 92121

Posting

Start Date:

04/29/26

WACKER is a world‑leading, research‑intensive chemical company dedicated to developing sustainable solutions that transform everyday life. We invite you to join our team in San Diego as a Principal Scientist in Bio Process Development.

• 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, timelines, regulatory phase, and manufacturing constraints; ensure compliance 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, definition, and comparability studies to support process changes or scale transitions.
• Author and review development protocols, SOPs, reports, technical documentation, and tech transfer documentation; support technical presentations and publications.
• Coordinate tech transfer with Manufacturing, QC, and MSAT; review 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.
• 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 in Biochemistry, Biological Sciences, Bioengineering, Chemistry, or related discipline;
  Master’s or PhD 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 preferred.
• Ability to travel up to 10%.
• Experience and good technical knowledge of biotherapeutic process development and manufacturing; proven track record of independent decision making on complex technical issues with risk assessment and escalation.
• In‑depth knowledge of upstream fermentation and downstream purification to support pipeline projects, platforms, and innovative technologies.
• Strong analytical skills and experience in process mapping and design.
• Proficiency in data analysis and performance measurement tools.
• Experience operating effectively in a client‑facing CDMO environment, balancing scientific rigor, timelines, and customer expectations; ability to clearly communicate complex technical concepts to diverse audiences.
• Extensive experience as a project lead for biologics pipeline programs; strong capability in managing evolving timelines, program risks, and mitigation strategies; strong understanding of phase‑appropriate development, including early‑stage, clinical, and commercial readiness considerations.
• Experience supporting or leading technical due diligence, feasibility assessments, and program onboarding activities; comfortable contributing to proposal development, technical justifications, and cost/scope discussions.
• Innovative mindset demonstrated by technical accomplishments, external presentations, and publications is a plus; commitment to awareness of emerging technologies, regulatory trends, and competitive landscape relevant to bioprocess development.
• Knowledge of authoring and providing critical input to regulatory submissions…