QC & Analytical Chemistry Manager

CSBio; Milpitas (CA); On-site; USD 130,000 - 180,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401k 10% match

PTO 10 days

Company paid holidays

Life insurance

Job summary

CSBio, a peptide CDMO, seeks a Manager of Quality Control to lead the QC laboratory and analytical chemistry function during a growth phase. You will oversee IPC strategy, final product release testing, stability studies, and regulatory readiness while reporting to the VP of Operations.

You will manage a small team of analysts, drive method validation per ICH Q2(R2), ensure data integrity, and lead audits/inspections with internal and client stakeholders.

Qualifications

• Degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related discipline.
• Experience leading QC laboratories or analytical teams.
• Strong knowledge of ICH Q2(R2) method validation, release testing, and cGMP batch testing.

Responsibilities

• Lead and mentor QC laboratory team of 5-8 analysts and chemists; establish performance metrics and training programs.
• Develop, validate, and implement analytical methods for peptide characterization (HPLC, LC-MS/MS, mass spectrometry, amino acid analysis).
• Manage IPC strategy, sampling plans, and real-time testing to support manufacturing decisions.
• Oversee final product release testing, batch records, and release dispositions.
• Design and execute stability studies and data integrity for regulatory submissions.
• Lead audit/inspection preparation and host regulatory/client audits.

Skills

HPLC

LC-MS

Analytical instrumentation

QA/QC leadership

FDA cGMP knowledge

Data integrity (21 CFR Part 11)

Process validation

Education

Chemistry/Analytical Chemistry/Pharmaceutical Sciences degree

Tools

LIMS

eQMS

Instrument maintenance

Job description

CSBio, a peptide CDMO, seeks a Manager of Quality Control to lead the QC laboratory and analytical chemistry function during a growth phase. You will oversee IPC strategy, final product release testing, stability studies, and regulatory readiness while reporting to the VP of Operations.

You will manage a small team of analysts, drive method validation per ICH Q2(R2), ensure data integrity, and lead audits/inspections with internal and client stakeholders.