Senior Bioassay Scientist - Lead Large-Molecule Analytics

Trident Consulting; Aliso Viejo (CA); Sur place; USD 118 000 - 148 000; Plein temps

Résumé du poste

Trident Consulting is seeking a Senior Bioassay Scientist for a client in Aliso Viejo, CA. The role focuses on developing, validating, and transferring analytical and bioassay methods to support large molecule drug development from early stages through commercialization.

The candidate will oversee stability studies, coordinate activities with CROs/CMOs, and serve as analytical lead on CMC project teams. Strong chromatographic expertise and regulatory experience are essential.

Qualifications

• Strong hands-on knowledge of chromatographic theory and technology.
• Ability to independently lead investigations and troubleshoot technical problems at all stages of development.
• Excellent written and verbal communication skills; experience in regulated environments (GxP, ICH, FDA).
• Strong ability to develop, validate and transfer methods; oversight of stability studies.
• Leadership as a subject matter expert in matrix teams and collaboration.
• Experience interacting with CROs and CMOs.
• Project management experience and knowledge of Quality systems in pharma.
• Ph.D. (8+ years) or MS (10+ years) in relevant field with 6+ years in large molecule analytical development and regulatory submissions.
• 1) Analytical Methodical developments for large molecules; 2) Collaboration with team; 3) Engage with CRO/CDMO.

Responsabilités

• Develop, validate, and transfer analytical and bioassay methods for large molecules.
• Oversee stability studies and perform trend analysis.
• Coordinate activities with internal teams, CROs and CMOs to ensure quality and timeliness.
• Represent analytical lead on CMC project teams and communicate data in meetings and reports.
• Prepare regulatory-quality reports and contribute to INDs/NDAs responses.
• Train and mentor scientists; participate in departmental committees.

Connaissances

Chromatography theory

Analytical method development

Data interpretation

Cross-functional collaboration

Regulatory compliance

Troubleshooting complex assays

Team leadership

Communication skills

CRO/CMO interaction

Formation

Ph.D. in biochemistry/analytical chemistry (8+ yrs)

MS in biochemistry/analytical chemistry (10+ yrs)

Outils

HPLC

UPLC

LC-MS

ELISA

ddPCR

qPCR

cIEF

Biacore

Description du poste

Trident Consulting is seeking a Senior Bioassay Scientist for a client in Aliso Viejo, CA. The role focuses on developing, validating, and transferring analytical and bioassay methods to support large molecule drug development from early stages through commercialization.

The candidate will oversee stability studies, coordinate activities with CROs/CMOs, and serve as analytical lead on CMC project teams. Strong chromatographic expertise and regulatory experience are essential.