Principal Scientist - BioProcess Development

Principal Scientist – BioProcess Development San Diego, CA, USA (92121) The Principal Scientist, BioProcess 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. Responsibilities 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. Position Requirements 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 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. Innovative mindset demonstrated by technical accomplishments, external presentations, and publications is a plus. Commitment to maintaining awareness of emerging technologies, regulatory trends, and competitive landscape relevant to bioprocess development. Knowledge of regulatory submissions including Investigational New Drug, Investigational Medicinal Product Dossier, and Clinical Trial Application 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. 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. The anticipated salary range for candidates who will work in San Diego is $140,000 – $155,000. The final salary offered will depend on several factors including experience, industry, and education. What do we offer? Wacker strives to reward its employees fairly. Our Total Rewards Package combines compensation, benefits, work‑life balance, recognition, and career development. 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 Wellbeing fund Flexible hybrid work arrangements 401(k) with company match Education Assistance Program Career development and advancement opportunities Support for community involvement The information contained herein is not intended to be an all‑inclusive list of the duties and responsibilities of the job, nor are they intended to be an all‑inclusive list of the skills and abilities required to do the job. A minimum requirement for this US‑based position is the ability to work legally in the United States on a permanent unrestricted basis. Visa sponsorship is not available for this position, including any type of US permanent residency (e.g. for a green card). Wacker is an Equal Opportunity Employer. We actively promote equality of opportunity for all qualified individuals regardless of age, disability, sex, race, religion or belief, marital status, pregnancy/maternity, sexual orientation, or any other protected characteristics. Selection for roles will be based on individual merit alone. #J-18808-Ljbffr Wacker Chemie AG