Principal Scientist - BioProcess Development
Principal Scientist - BioProcess DevelopmentLocation: San Diego, CA, USA 92121Posting Start Date: 04/29/26WACKER 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 BioProcess Development.ResponsibilitiesLead 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.Position RequirementsBachelor 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 including Investigational New Drugs, Investigational Medicinal Product Dossiers, and Clinical Trial Applications is a plus.Ability to work closely with cross-functional stakeholders to ensure team alignment with functional objectives; ability to manage ambiguity and rapidly evolving priorities across multiple client programs and internal initiatives.Ability to lead technically without direct authority; demonstrated ability to mentor and elevate technical capability of junior scientists through coaching and review.Strong collaboration skills in matrixed and cross-functional organizations, including global or multi-site teams; willingness to support occasional non-standard work hours to meet critical project milestones.Anticipated salary range for San Diego: $140,000 – $155,000. Final salary will depend on experience, education, and other factors.What do we offer?Competitive compensation and incentive plans.Medical, dental, and vision insurance effective day 1.Paid time off in addition to personal days and holidays.Paid parental leave.Well-being fund.Flexible hybrid work arrangements.401(k) with company match.Education assistance program.Career development and advancement opportunities.Support for community involvement.Reference Code: 30937The information contained herein is not an all-inclusive list of duties, responsibilities, or required skills. This U.S.-based position requires the ability to work legally in the United States on a permanent unrestricted basis. Visa sponsorship is not available for this position.Wacker is an Equal Opportunity Employer. We actively promote the equality of opportunity for all who are qualified and bring the requisite experience, talent, skill, and potential, without regard to age, disability, sex, race, religion or belief, marriage/civil partnership, pregnancy/maternity, sexual orientation, or any other protected characteristics.J-18808-Ljbffr