Principal Scientist - BioProcess Development

Job Title: Principal Scientist – BioProcess Development Location: San Diego, CA, USA 92121 Posting Start Date: 4/29/26 Do you want to take responsibility and make a difference with your work? With your expertise, we can achieve great goals together. We are WACKER – Reliable. Determined. Ambitious. As one of the world’s most research‑intensive chemical companies, we have been making countless products that are an integral part of everyday life for over 100 years. From vegan food to resource‑efficient buildings to solar cells, we develop sustainable solutions that change the future. To strengthen our team in San Diego, we are looking for you as a Principal Scientist – BioProcess Development. The Principal Scientist, BioProcess Development is a senior technical leadership role responsible for the design, development, optimisation, 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 programme execution. The Principal Scientist independently leads complex development programmes, drives platform and technology innovation, and ensures successful technology transfer to Manufacturing and MSAT. Responsibilities Lead complex upstream/downstream bioprocess development programmes. Act as technical escalation point for complex process, scale‑up, and manufacturability challenges across development programmes. 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, development SOPs, development 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 modelling, process economics, and capacity planning discussions. Represent Process Development in cross‑functional decision‑making related to programme strategy, timelines, and risk. Contribute to platform and continuous improvement initiatives. Champion standardisation, 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 Ph.D. 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, LNP preferred. Ability to travel up to 10%. Experience in and good technical knowledge of biotherapeutic process development and manufacturing is required. Proven track record of independent decision‑making on complex technical issues with appropriate risk assessment and escalation. High level of scientific accountability and ownership, with a proactive approach to problem‑solving. In‑depth knowledge in upstream fermentation process development and downstream purification development to support development of pipeline projects, platforms, and innovative technologies. Strong analytical skills with experience in process mapping and process 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 programmes. Strong capability in managing evolving timelines, programme 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 programme 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 maintaining awareness of emerging technologies, regulatory trends, and competitive landscape relevant to bioprocess development. Knowledge in authoring and providing critical input to regulatory submissions including but not limited to 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 programmes and internal initiatives. Ability to lead technically without direct authority. Demonstrated ability to mentor and elevate technical capability of junior scientists through coaching, review, and example. Strong collaboration skills in matrixed and cross‑functional organisations, including global or multi‑site teams. Willingness to support occasional non‑standard work hours to meet critical project milestones. What we offer WACKER strives to reward its employees in a fair and equitable manner. Our Total Rewards Package considers employee wellbeing and is comprised of compensation, benefits, work‑life balance, performance & 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 Programme Career development and advancement opportunities Support for Community Involvement Salary The anticipated salary range for candidates who will work in San Diego is $140,000 – $155,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Wacker is a multi‑state employer and this salary range may not reflect positions that work in other states. Legal & Equal Opportunity 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 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. We welcome all applications from a wide range of candidates. Selection for roles will be based on individual merit alone. #J-18808-Ljbffr Wacker Chemie AG