Senior Biologics Analytics Lead – CMC

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

Job summary

Planet Pharma seeks an experienced analytical leader to develop, validate, and transfer potency and bioassay methods for large molecule programs. You will oversee stability testing, data interpretation, and cross‑functional collaboration to ensure timely project delivery.

The role entails communicating findings in group settings and reports, mentoring scientists, and representing analytical science on CMC project teams to support regulatory submissions.

Qualifications

• ,

Responsibilities

• Lead analytical development, transfer methods, and regulatory submissions for large and small molecules.
• Oversee stability studies and trend analysis in collaboration with CROs/CMOs.
• Prepare CMC sections of INDs/NDAs and respond to regulatory questions.

Skills

Chromatography theory

HPLC/UPLC

LC-MS

CE techniques

QbPCR/ddPCR

Protein/biologics analysis

Analytical development

Education

Ph.D. in biochemistry/analytical chemistry

M.S. in biochemistry/analytical chemistry

Tools

HPLC

UPLC

IEX-HPLC

SEC-HPLC

LC-MS

qPCR

ddPCR

Octet

Biacore

Job description

Planet Pharma seeks an experienced analytical leader to develop, validate, and transfer potency and bioassay methods for large molecule programs. You will oversee stability testing, data interpretation, and cross‑functional collaboration to ensure timely project delivery.

The role entails communicating findings in group settings and reports, mentoring scientists, and representing analytical science on CMC project teams to support regulatory submissions.