Analyst, QC II
300 Bel Marin Keys Boulevard Novato, CA 94949
QC Analyst II
Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases
Analyze and review quality control release and stability testing data of pharmaceutical products at Contract Testing Laboratories (CTLs) and/or Contract Manufacturing Organizations (CMOs)
Support the preparation of phase-appropriate stability protocols and stability reports for API and drug product in accordance with regulatory requirements and as needed to support clinical trials and regulatory submissions
Support investigations conducted at CMO/CTL and review and approve out-of-specification (OOS), out-of-trend (OOT) and out-of-expectation (OOE) testing results, deviations.
Support the transfer of analytical methods to CTL’ s for gene therapy products. These methods may include HPLC, ELISA, and other methods, such as cell-based potency methods.
Support continuous improvement in quality systems (procedures and systems) to improve organizational effectiveness, quality assurance compliance, and regulatory and other requirements (cGMP, ICH).
Work collaboratively with manufacturing/supply chain, quality assurance, regulatory, and project management to ensure timely availability of lot release, stability data, and other required analytical data.
- Relevant experience in a Quality Control function at an Analyst or technician level is highly preferred.
- Experience with analytical systems (LIMS, laboratory control systems, stability/release systems) is preferred.
- Basic understanding of regulatory agency (FDA) requirement and international guidance (ICH) for drug substance and product under GMP is required as applied to biologics is preferred.
- Demonstrated experience with passaging cells and cell-based methods is highly preferred. Experience with PCR and molecular biology methodologies is preferred.
- Ability to effectively prioritize and deliver on tight timelines in a fast-paced environment.
- Excellent written and verbal communication skills is required.
- Experience in analytical data systems is preferred.
- Accuracy and attention to detail is required.
- Excellent cross-functional team participation skills.
- Basic problem-solving abilities.
- Ability to be flexible with changing work needs
- Interacts with other functional leaders, project management and QC/AD team personnel
- Interacts with Contract Testing Laboratories, Contract Manufacturing Organizations, consultants and external partners
- BS in Molecular Biology, Genetics, Chemistry, Biochemistry, Analytical Chemistry, or a related field (with 0 - 2 years professional experience).
- MS in Molecular Biology, Genetics, Chemistry, Biochemistry, Analytical Chemistry, or a related field (with 0 years professional experience).