Senior Bioanalytical Strategy Lead, QC & CRO Oversight

5Amventures

Emeryville (CA)

On-site

USD 150,000 - 210,000

Full time

14 days+

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Job summary

5Amventures seeks an experienced, highly quantitative scientist to lead bioanalytical strategy and quality control across a diverse portfolio of peptide, protein, and small molecule therapeutics. This role will define analytical approaches, oversee external CROs, and ensure data are accurate, reproducible, and decision-grade.

The ideal candidate combines deep bioanalytical knowledge with a strong QC mindset and can diagnose and resolve complex challenges across multiple assay platforms.

Qualifications

PhD in Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, or related field.
8–15+ years of relevant experience in biotech, pharma, or CRO environments.
Demonstrated expertise in bioanalytical method development, validation, and data interpretation within a quality management system (i.e. GLP / GMP).

Responsibilities

Define fit-for-purpose analytical approaches for drug substance and product.
Oversee outsourced bioanalytical studies and CRO data.
Ensure data are accurate, reproducible, and decision-grade across programs.
Lead data interpretation within GLP/GMP framework.

Skills

Bioanalytical strategy

QC mindset

CRO oversight

GLP/GMP

Data interpretation

Chemical kinetics

RP-HPLC/UPLC

LC-MS

Quality data integrity

Education

PhD in Analytical Chemistry or related

Tools

RP-HPLC/UPLC

SEC

LC-MS

Colorimetry

Viscosity

Osmolarity

Endotoxin

Bioactivity

Job description

The ideal candidate combines deep bioanalytical knowledge with a strong QC mindset and can diagnose and resolve complex challenges across multiple assay platforms.

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