Principal Engineer/Scientist

Bora Biologics USA LLC; Rockville (MD); On-site; USD 142,000 - 200,000; Full time

Benefits offered by this job

Competitive salary and incentives

Health coverage

Retirement plan

Paid time off

Professional development opportunities

Job summary

Bora Biologics USA LLC is seeking a Principal Engineer/Principal Scientist for Cell Culture Sciences. This role leads mammalian cell culture processes from development through commercialization, directing studies, transfer to GMP manufacturing, and regulatory documentation.

You will partner cross‑functionally to ensure timelines and deliverables across client programs, while mentoring staff. The position emphasizes scalable, compliant processes, data‑driven decision making, and continuous

Qualifications

• Ph.D./Masters/Bachelors with extensive industry experience in mammalian cell culture and harvest development.
• Hands‑on experience with fed‑batch culture, bench to intermediate bioreactors, and scale‑up.
• Strong knowledge of FDA/ICH guidelines for biologics and data‑driven process characterization.

Responsibilities

• Lead cell culture and harvest studies, including process development and tech transfer to GMP manufacturing.
• Develop control strategies, study plans, and regulatory documentation for client programs.
• Coach and mentor direct reports; manage multiple projects across development and manufacturing.
• Communicate complex data and results effectively to internal teams and clients.

Skills

Mammalian cell culture

Harvest process development

Technology transfer

Process characterization

Regulatory documentation

Leadership

Education

Ph.D. in relevant field

Masters in relevant field

Bachelors in relevant field

Tools

Depth filtration

Centrifugation

Bioreactor scale‑up

DOE

QbD

JMP

Job description

About Bora: Bora Biologics is a global biologics CDMO delivering integrated development and GMP manufacturing solutions from First‑in‑Human through licensed commercial supply. While many CDMOs are structured primarily for early clinical programs, Bora Biologics is purpose‑built for commercialization. Our inspection‑proven, bi‑coastal U.S. manufacturing platform and integrated development center provide the infrastructure, regulatory discipline, and operational precision required for sustained global market supply.

Job Summary

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.

Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. 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. Oversees 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.

Minimum Education, Experience & Skills

• Minimum Requirements Education: 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, Or 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, Or 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.
• Experience: 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.
• Required Knowledge and Skills: 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.
• Preferred Qualifications: 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.

Salary Range

Salary Range: $142,000-$200,000

Compensation and Benefits

We offer a comprehensive benefits package designed to support our employees’ wellbeing, including:

• Competitive salary and performance‑based incentives
• Comprehensive health coverage including medical, dental, and vision insurance
• Retirement savings plans with employer matching contributions
• Paid time off
• Professional development opportunities
• Employee wellness programs and resources
• Employee Assistance Program and Mental Health Resources

Core Values

At Bora, our values guide everything we do — from how we solve challenges to how we support our people. We lead with a solutions‑first mindset, strive to do the right thing, stay proactive, and above all, respect everyone.

Bora Pharmaceuticals is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category.

Bora Pharmaceuticals is focused on developing and manufacturing branded, generic and over the counter (OTC) healthcare and pharmaceutical products for patients around the globe. At Bora Pharmaceuticals, we see it as our mission and our duty to make our mutual success more certain. As an ambitious, future‑focused company, we know better than most that our own success is shaped by our partners victories.