Quality Control Scientist, Controls
Capricor Therapeutics, Inc.
4 hours ago
On-site
San Diego, CA
$95,000 - $115,000 USD yearly
Operations
Responsibilities:
- Lead the development, qualification, and maintenance of positive and negative control materials used in QC analytical assays.
- Establish and oversee assay control strategies to ensure reliable assay performance and consistency across QC testing programs.
- Serve as the scientific owner for control materials within the analytical lifecycle framework (control generation, qualification, monitoring, lifecycle management).
- Design and execute analytical studies to evaluate assay performance, control suitability, assay robustness, and method reliability.
- Provide scientific leadership for assay troubleshooting and optimization to improve robustness and reproducibility.
- Evaluate assay performance trends and control performance data to identify opportunities for improving assay reliability.
- Analyze experimental data, interpret results, and generate scientific reports, study summaries, and technical documentation.
- Document experimental work and study outcomes in accordance with GMP and data integrity requirements.
- Support preparation and maintenance of technical documentation (study protocols, reports, SOP updates, control qualification records, analytical lifecycle documentation).
- Support regulatory inspection readiness by ensuring analytical control strategies and study records meet regulatory expectations.
- Provide scientific support for investigations including deviations, OOS/OOT events, and assay performance issues.
- Collaborate with Analytical Development, Process Development, Manufacturing, and Quality teams on assay lifecycle management and continuous improvement.
- Manage multiple scientific projects and timelines to support QC priorities.
- Perform additional QC duties as assigned.
Required Qualifications (Must-Haves):
- Ph.D. in Biological Sciences, Biochemistry, Molecular Biology, Bioengineering, or related discipline.
- Strong background in primary cell culture and analytical assay development, troubleshooting, and experimental design.
- Hands-on experience with analytical techniques such as ELISA, PCR/qPCR, flow cytometry, or other biochemical/cell-based assays.
- Experience designing/executing analytical studies and interpreting experimental data.
- Strong understanding of assay controls, performance monitoring, and analytical method lifecycle management.
- Strong written and verbal communication skills.
- Ability to work independently and manage multiple projects in a fast-paced environment.
Preferred Qualifications (Nice-to-Haves):
- Experience working in GMP or regulated laboratory environments.
- Experience supporting analytical method qualification, validation, or lifecycle management.
- Experience working with cell-based assays or mammalian cell culture systems.
- Experience supporting deviations, assay investigations, or technical reports in regulated environments.
- Experience with cell therapy, biologics, or exosome-based products.
Work Environment & Physical Requirements:
- Laboratory-based role with routine bench work.
- Analytical instrumentation, laboratory documentation, and computer-based data analysis.
- Ability to lift up to 20 pounds.
- Occasional participation in cross-functional meetings and technical discussions.
- Lead the development, qualification, and maintenance of positive and negative control materials used in QC analytical assays.
- Establish and oversee assay control strategies to ensure reliable assay performance and consistency across QC testing programs.
- Serve as the scientific owner for control materials within the analytical lifecycle framework (control generation, qualification, monitoring, lifecycle management).
- Design and execute analytical studies to evaluate assay performance, control suitability, assay robustness, and method reliability.
- Provide scientific leadership for assay troubleshooting and optimization to improve robustness and reproducibility.
- Evaluate assay performance trends and control performance data to identify opportunities for improving assay reliability.
- Analyze experimental data, interpret results, and generate scientific reports, study summaries, and technical documentation.
- Document experimental work and study outcomes in accordance with GMP and data integrity requirements.
- Support preparation and maintenance of technical documentation (study protocols, reports, SOP updates, control qualification records, analytical lifecycle documentation).
- Support regulatory inspection readiness by ensuring analytical control strategies and study records meet regulatory expectations.
- Provide scientific support for investigations including deviations, OOS/OOT events, and assay performance issues.
- Collaborate with Analytical Development, Process Development, Manufacturing, and Quality teams on assay lifecycle management and continuous improvement.
- Manage multiple scientific projects and timelines to support QC priorities.
- Perform additional QC duties as assigned.
Required Qualifications (Must-Haves):
- Ph.D. in Biological Sciences, Biochemistry, Molecular Biology, Bioengineering, or related discipline.
- Strong background in primary cell culture and analytical assay development, troubleshooting, and experimental design.
- Hands-on experience with analytical techniques such as ELISA, PCR/qPCR, flow cytometry, or other biochemical/cell-based assays.
- Experience designing/executing analytical studies and interpreting experimental data.
- Strong understanding of assay controls, performance monitoring, and analytical method lifecycle management.
- Strong written and verbal communication skills.
- Ability to work independently and manage multiple projects in a fast-paced environment.
Preferred Qualifications (Nice-to-Haves):
- Experience working in GMP or regulated laboratory environments.
- Experience supporting analytical method qualification, validation, or lifecycle management.
- Experience working with cell-based assays or mammalian cell culture systems.
- Experience supporting deviations, assay investigations, or technical reports in regulated environments.
- Experience with cell therapy, biologics, or exosome-based products.
Work Environment & Physical Requirements:
- Laboratory-based role with routine bench work.
- Analytical instrumentation, laboratory documentation, and computer-based data analysis.
- Ability to lift up to 20 pounds.
- Occasional participation in cross-functional meetings and technical discussions.