Senior Bioprocess Engineer, Cell Culture & Tech Transfer

Bora Biologics USA LLC; Rockville (MD); Presencial; USD 142.000 - 200.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salary and incentives

Health coverage

Retirement plan

Paid time off

Professional development opportunities

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Mammalian cell culture

Harvest process development

Technology transfer

Process characterization

Regulatory documentation

Leadership

Educación

Ph.D. in relevant field

Masters in relevant field

Bachelors in relevant field

Herramientas

Depth filtration

Centrifugation

Bioreactor scale‑up

DOE

QbD

JMP

Descripción del empleo

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