Job Description
Testing incoming raw materials like those for cell therapies ensures they meet specifications for Duchenne muscular dystrophy treatments, vital for patient safety using rapid cell analysis. This role involves preparing samples, reagents, and performing routine checks with tools like FTIR, endotoxin testing, or wet chemistry, helping guarantee product quality in late-stage drug development where Deramiocel (CAP-1002) relies on precise components for effective exosome therapies.
Capricor Therapeutics focuses on cell and exosome-based therapies for rare diseases, advancing Deramiocel for DMD and StealthX for targeted delivery in vaccinology. They prioritize scientific boundaries and patient-changing impacts, passionate about healthcare transformations.
In this job, you perform routine testing according to approved SOPs in GMP labs, document results in notebooks and electronic systems, identify OOS, document irregularities, support investigations, maintain cleanliness and safety with equipment like analytical instruments. Interactions include QC, QA, Procurement, Manufacturing teams for material readiness, supporting audits and training with a constraint of handling regulated environments requiring strict data integrity.
No salary range provided; work is laboratory-based, full-time onsite with prolonged computer use and lifting up to 20 pounds for sampling. Benefits emphasize professional growth, innovation in therapies, mission-driven collaboration, no Skype for calls.
Responsibilities
- Perform routine quality control testing of raw materials per specifications
- Prepare samples, reagents, standards for testing
- Accurately document test results in notebooks, forms, systems
- Identify, document, report OOS or atypical results to superiors
- Support investigations, deviations, CAPA
- Maintain lab organization, cleanliness, safety, GMP
- Assist with equipment operation, calibration, maintenance
- Follow all GMP, safety, compliance procedures
- Collaborate with QC, QA, Manufacturing, Supply Chain for material testing and release
- Participate in training, audits, improvement initiatives
Requirements
- Bachelor’s degree in Life Sciences, Chemistry, Biotechnology, or related
- Strong attention to detail and ability to follow SOPs
- Understanding of lab techniques, reagent handling, instrumentation
- Solid documentation skills for multiple samples
- Familiarity with GMP or regulated labs
- Working knowledge of GMP, quality systems, workflows (preferred)
- Experience with FTIR, endotoxin, wet chemistry (preferred)
- Proficiency with LIMS and Microsoft Office (preferred)
- Strong communication and team-working skills (preferred)