Principal Engineer/Scientist

Bora Pharmaceuticals•Rockville, MD

13d•$142,000 - $200,000

About The Position

The Principal Engineer, or Principal Scientist, at Cell Culture Sciences is a technical leader and hands-on expert responsible for mammalian cell culture and harvest bioprocess development, optimization, characterization, and validation across multiple client programs within a CDMO environment. This key team member is responsible for delivering robust, scalable, and regulatory-compliant processes to support diverse molecules from development through commercialization. This role will lead the design and execution of studies, and interpretation of study results, develop control strategies, and apply data-driven approaches to enable efficient process development and technology transfer. This individual will partner cross-functionally with internal teams (other development function, Manufacturing, Supply Chain) and act as a key technical interface with clients, ensuring alignment on development strategies, timelines and deliverables. This role will also provide technical leadership in support of client programs, including preparing technical reports and regulatory documentation, contributing to proposals and study plans, to support client interactions. This role will require a strong ability to manage multiple projects simultaneously, adapt to varying client needs, and drive scientific excellence while meeting timelines. The role will also manage team members and contribute to continuous improvement and innovation across the organization.

Requirements

Ph.D. in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Biochemistry or related technical fields, and a minimum of 6 years of industry experience in mammalian cell culture and harvest process development of biologics
Masters’ degree in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Biochemistry processing or related technical fields and a minimum of 12 years of industry experience in areas described above
Bachelors’ degree in Chemical Engineering, Biochemical Engineering, Biomedical Engineering, Biochemistry or related technical fields and a minimum of 14 years of industry experience in areas described above.
Significant hands-on experience in mammalian cell culture in fed-batch mode, with bench to intermediate scale-bioreactors, developing high-titer cell culture processes and process scale-up.
Hands-on experience in unit operations of harvest steps, including depth filtration and centrifugation.
Experience in early- and late-stage cell culture process development activities and process characterization for cell culture unit operations.
At least 5 years’ experience in managing direct reports; coaching, mentoring and/or training team members.
Knowledge and in-depth understanding of mammalian cell culture, harvest, and bioprocess equipment as well as biochemical engineering principles. Comprehensive knowledge of mammalian protein expression and large-scale cell culture techniques as well as depth filtration.
Proven ability to solve technical and scientific problems.
Ability to critically analyze data, question experimental results, perform root cause analysis, and to organize data and review technical reports.
Strong understanding of statistical tools (such as JMP), DOE and QbD principles, with the ability to apply advanced statistical analysis and data-driven modeling to support process development and Process Characterization.
Strong expertise in bioreactor scale-up principles, including scale-up/scale-down modeling and process comparability across scales.
Strong organizational skills and ability to prioritize and execute multiple projects to completion
Ability to set up, maintain, and troubleshoot equipment and drive implementation of new technologies and techniques for process development and commercial production
Strong verbal, presentation and writing skills to communicate effectively internally and externally
Experience in working in CMC teams.
Ability to lead cross-functional teams, be collaborative, and represent the cell culture team and align stakeholders across internal functions and client organizations
Willingness to work on weekends.
Solid understanding of current FDA and ICH guidelines regarding cell culture/drug substance processes for biologics.

Nice To Haves

Experience in cell culture in perfusion mode, including (N-1) perfusion.
Experience in sizing depth filters for harvest operation.
Experience in using acidification or coagulation for harvest.
Experience in Cell Line Development, and knowledge in CHO cell functions.
Experience in cell banks, and knowledge in relevant regulatory requirements.
Experience applying advanced data analytics, such as mechanistic modeling, data visualization, predictive analytics, or machine learning approaches, to bioprocess development and process characterization.
Familiarity with data communication and SCADA systems.
Track record of authoring, planning, executing and reviewing both small- and large-scale Process Validation protocols, including LIVCA and EOPCB studies

Responsibilities

Leads, designs, and performs studies on cell culture and harvest unit operations for client programs, including process development, scale-up, toxicology material production, raw materials strategies, technology transfer. Supports development of clinical and commercial processes for a diverse portfolio of client molecules and modalities.
Leads the technology transfer of cell culture and harvest processes to GMP manufacturing. Provides support to manufacturing throughout the product life cycle, including campaign monitoring, data analysis, equipment recommendations and regulatory support.
Presents at internal, client-facing, and external meetings, effectively communicating technical information to audience.
Develops strategic goals and leads efforts for late-stage process development strategies, including the planning and execution of Process Characterization and small- and large-scale Process Validation studies.
Oversee the operation and maintenance of equipment and instrument; Implements best practices as part of robust process development strategy and technology transfer to manufacturing.
Provides supervision to ensure all work is performed in a compliant manner and meets applicable regulatory guidelines. Continuously improves safety and lab procedures.
Performs all supervisory responsibilities for direct report(s). Provides coaching and mentoring to direct report(s). Foster a culture of accountability, responsiveness, and client focus
Serves as a resource for the department and project teams, proactively bringing updates on current scientific trends and technical aspects from conferences, local meetings, and literature.
Advances the development of lab technologies, procedures and equipment reliability to ensure experimental and process robustness at small and large scales and alignment with manufacturing capabilities.
Leads Continuous Improvement initiatives to enhance efficiency, process scalability, and delivery to clients.