Principal Scientist, Cell Culture & Process Development

Bora Pharmaceuticals; Rockville (MD); Hybrid; USD 142,000 - 200,000; Full time

Benefits offered by this job

Health coverage including medical, den

Retirement savings with employer match

Paid time off

Professional development opportunities

Job summary

Bora Pharmaceuticals in Rockville, MD is seeking a Principal Engineer/Scientist to lead mammalian cell culture and harvest bioprocess development across client programs, ensuring scalable, regulatory-compliant processes from development through commercialization.

This role partners with Manufacturing, Supply Chain, and clients to design studies, drive technology transfer, and deliver robust processes and regulatory documentation.

Qualifications

• Ph.D. or equivalent with substantial industry experience in mammalian cell culture and harvest process development.
• Experience leading cross-functional development programs and technology transfer.
• Strong regulatory knowledge and ability to prepare tech reports and regulatory documentation.

Responsibilities

• Lead design and execution of cell culture and harvest studies across client programs.
• Drive technology transfer to GMP manufacturing and support process characterization.
• Provide supervision, coaching, and mentoring to direct reports and cross-functional teams.
• Communicate findings effectively to clients and internal stakeholders.

Skills

Mammalian cell culture

Bioprocess development

Technology transfer

Regulatory documentation

Project leadership

Data analysis

DOE & QbD

Education

Ph.D. in Chemical Engineering

Master's in Chemical Engineering

Bachelor's in Chemical Engineering

Tools

JMP

SCADA systems

Job description

Bora Pharmaceuticals in Rockville, MD is seeking a Principal Engineer/Scientist to lead mammalian cell culture and harvest bioprocess development across client programs, ensuring scalable, regulatory-compliant processes from development through commercialization.

This role partners with Manufacturing, Supply Chain, and clients to design studies, drive technology transfer, and deliver robust processes and regulatory documentation.