Senior Analytical Scientist — Large Molecule CMC Lead

Planet Pharma; Aliso Viejo (CA); On-site; USD 118,000 - 148,000; Full time

Job summary

Planet Pharma is seeking an experienced analytical leader to drive development, validation, and transfer of analytical and biological potency assays for large molecules. You will oversee stability studies, coordinate CRO/CMO activities, and contribute to CMC sections for regulatory submissions.

The role requires strong leadership, regulatory acumen, and the ability to mentor scientists while delivering high-quality data to support drug development programs.

Qualifications

• Ph.D./M.S. with extensive pharma analytical experience.
• Experience leading analytical development for large/molecule drugs.
• Strong regulatory and cGMP knowledge for submissions.

Responsibilities

• Lead development, validation, and transfer of analytical methods for large molecules.
• Oversee stability studies and perform trend analyses.
• Coordinate activities with CROs/CMOs to ensure timely project delivery.
• Act as analytical lead on CMC teams and support regulatory responses.
• Mentor scientists and communicate progress to management.

Skills

Leadership

Project management

Regulatory knowledge

Written communication

Troubleshooting

Cross-functional collaboration

Education

Ph.D. in biochemistry/analytical chemistry

M.S. in biochemistry/analytical chemistry

Tools

HPLC

UPLC

LC-MS

CE techniques

cIEF

ELISA

qPCR

Octet/Biacore

Job description

Planet Pharma is seeking an experienced analytical leader to drive development, validation, and transfer of analytical and biological potency assays for large molecules. You will oversee stability studies, coordinate CRO/CMO activities, and contribute to CMC sections for regulatory submissions.

The role requires strong leadership, regulatory acumen, and the ability to mentor scientists while delivering high-quality data to support drug development programs.