Senior Scientist, Cell Culture Process Development (Pivotal/Commercial)

Gilead Sciences Inc.; Maryland; Sur place; USD 169 000 - 219 000; Plein temps

Avantages offerts par ce poste

Medical, dental, vision plans

Discretionary bonus

Stock-based incentives

Paid time off

Résumé du poste

Gilead Sciences Inc. is seeking a Senior Scientist, Cell Culture Process Development, to lead pivotal-phase development, characterization, and regulatory support for biologics programs.

The role includes cross-functional collaboration with MSAT, technology transfer, and hands-on operations across shake flasks to pilot-scale bioreactors. The ideal candidate will possess a PhD/PharmD or equivalent experience with strong writing, communication, and problem-solving skills.

Qualifications

• Bachelor’s degree with 8+ years in cell culture development or related field.
• Or a Master’s degree with 6+ years of industry experience.
• PhD/PharmD with relevant biologics experience is preferred.

Responsabilités

• Lead and coordinate pivotal stage cell culture development and characterization.
• Prepare documentation and reports for BLA submissions and PPQ readiness.
• Support technology transfer and collaboration with MSAT teams.
• Design experiments and conduct hands-on culture operations at multiple scales.
• Develop novel cell culture platforms and optimize process parameters.
• Mentor team members and oversee budget adherence and compliance.

Connaissances

Cell culture development

Process characterization

GMP documentation

Regulatory submissions

Formation

Bachelor's degree + 8 years

Master's degree + 6 years

PhD/PharmD

Outils

JMP

Spotfire

Lab automation

Bioreactors

Description du poste

Gilead Sciences Inc. is seeking a Senior Scientist, Cell Culture Process Development, to lead pivotal-phase development, characterization, and regulatory support for biologics programs.

The role includes cross-functional collaboration with MSAT, technology transfer, and hands-on operations across shake flasks to pilot-scale bioreactors. The ideal candidate will possess a PhD/PharmD or equivalent experience with strong writing, communication, and problem-solving skills.