Senior QC Lead – Peptide GMP & IND Support

Mixtalent; Milpitas (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

Mixtalent is seeking an Associate Director, Quality Control to lead daily QC operations, own IND support studies, release and stability programs, and CAPA processes across clinical and commercial peptide programs while maintaining GMP standards.

The role combines hands‑on laboratory leadership with strategic governance, ensuring timely batch disposition and strong QA, Regulatory, and Manufacturing partnerships in a fast‑moving, risk‑based environment.

Qualifications

• B.S., M.S., or Ph.D. in Analytical Chemistry, Chemistry, Biochemistry, Pharmaceutical Sciences, or a closely related scientific discipline.
• Typically 8–12+ years of progressive analytical and QC experience in GMP pharma, biotech, or CDMO environments, with at least 3 years in leadership or senior IC role.
• Hands‑on proficiency with HPLC, LC‑MS, and UV‑based analytical methods relevant to peptide API characterization, including purity, identity, impurity profiling, and stability testing.
• Ownership of OOS/OOT investigations — including Phase I laboratory investigation execution and Phase II root cause analysis — under 21 CFR 211.192 and FDA OOS guidance expectations.
• Working knowledge of analytical method validation and transfer per ICH Q2(R1) and USP requirements in a GMP QC context.
• Familiarity with phase‑appropriate GMP requirements for clinical trial API material under 21 CFR Part 211 and ICH Q7; ability to calibrate QC standards appropriately across early‑phase and commercial programs.
• Demonstrated ability to work effectively in a fast‑moving, deadline‑driven, CDMO or similarly dynamic organization where priorities shift and QC decisions must be made with urgency and sound risk judgment.
• Strong communication and collaboration skills across QA, Manufacturing, Regulatory, and client‑facing functions.
• Familiarity with Empower, or equivalent data systems expected given the analytical scope of the role.

Responsibilities

• Oversee daily QC operations, including IND support studies and validations, release testing, stability programs, and reference standard programs.
• Ensure testing is accurate, documented, and on time to support batch release across clinical and commercial programs.
• Monitor laboratory execution, identify gaps, and prioritize QC workload based on compliance risk and deadlines.
• Maintain instrument qualification, method lifecycle management, and readiness for FDA and client audits.

Skills

Leadership

Communication

Collaboration

Risk-based decision making

Education

B.S., M.S., or Ph.D. in Analytical Chemistry or related

Tools

HPLC

LC-MS

UV-based methods

Empower (data systems)

Job description

Mixtalent is seeking an Associate Director, Quality Control to lead daily QC operations, own IND support studies, release and stability programs, and CAPA processes across clinical and commercial peptide programs while maintaining GMP standards.

The role combines hands‑on laboratory leadership with strategic governance, ensuring timely batch disposition and strong QA, Regulatory, and Manufacturing partnerships in a fast‑moving, risk‑based environment.