Principal Scientist - BioProcess Development

Wacker•San Diego, CA

4d•Hybrid

About The Position

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.

Requirements

Bachelor of Science degree in Biochemistry, Biological Sciences, Bioengineering, Chemistry, or related scientific discipline.
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.
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 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.
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, review, and example.
Strong collaboration skills in matrixed and cross functional organizations, including global or multi-site teams.
Willingness to support occasional nonstandard work hours to meet critical project milestones.
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).

Nice To Haves

Master’s Degree or PhD in Biology, Chemistry, Engineering or related scientific field is preferred.
Additional experience in RNA, LNP preferred.
Innovative mind-set 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 the regulatory submissions including but not limited to Investigational New Drugs, Investigational Medicinal Product Dossiers, and Clinical Trial Applications is a plus.

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, 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 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.