Company Overview
Applied BioCode is an innovative IVD (In Vitro Diagnostic) company specializing in the design, development, and commercialization of multiplex testing products. Leveraging cutting-edge digital barcode technology combined with immuno- and molecular chemistry, the company pioneers advanced bio-inspired diagnostic solutions with a promising pipeline targeting bacterial and fungal pathogen detection and antimicrobial resistance markers.
Job Summary
We are seeking a highly skilled Manufacturing Chemist to join our dynamic team. The successful candidate will be responsible for supporting the development, manufacturing, and quality oversight of buffers, reagents, and chemical components used in diagnostic assay production. This role serves as the subject matter expert (SME) for all in-house manufactured chemical formulations, ensuring consistency, performance, and compliance with regulatory and quality standards. The Chemist partners cross functionally with manufacturing, Quality, R&D, and Supply Chain to support product lifecycle activities, troubleshoot issues, and drive continuous improvement in formulation and production processes.
Our culture is built on integrity, innovation, and teamwork, all driven by a shared mission to positively impact patients' lives.
Duties
- Develop, optimize, and manufacture buffer and reagent formulations to support diagnostic assay performance and stability.
- Support manufacturing operations by performing & overseeing buffer preparation, ensuring adherence to validated processes and specifications.
- Serve as the subject matter expert (SME) for all in-house manufactured chemicals/buffers, providing technical guidance across departments.
- Autor, review, and maintain batch records, standard operating procedures, (SOPs), specifications, and technical reports in compliance with GxP requirements.
- Investigate nonconformances, deviations, and out-of-specification (OOS) results related to chemical components, support root cause analysis, and CAPA activities.
- Perform and/or support method development, verification, and transfer activities for analytical testing of buffers and reagents.
- Ensure compliance with applicable regulatory standards, including ISO 13485, FDA QSR/QMSR, and internal quality systems.
- Collaborate with Product Development and Validation teams to scale up formulations and transfer processes into manufacturing.
- Evaluate raw materials, qualify new vendors, and assess impact of material changes on product performance.
- Support stability studies and shelf-life determinations for reagents and buffers.
- Maintain accurate documentation and ensure data integrity in accordance with ALCOA+ principles.
- Drive continuous improvement initiatives to enhance robustness, efficiency, and reproducibility of chemical manufacturing processes.
Education
- Master's degree in Chemistry or Biochemistry. Polymer or organic chemistry preferred.
Experience
- Strong knowledge of buffer chemistry, reagent preparation, and analytical techniques (e.g. pH, conductivity, spectrophotometry0 .
- Working knowledge of GxP requirements, including ISO 13485 and/or FDA 21 CFR Part 820/QMSR.
- Experience with technical documentation, including SOPs, batch records, and investigation reports.
- Strong problem-solving and root cause analysis skills.
- Experience in a regulated laboratory or molecular diagnostics manufacturing environment (IVD, biotech, or pharmaceutical).
- Familiar with stability studies, design of experiments, and process validation.
- Experience supporting audits and regulatory inspections.
- Polymer Chemist with experience in wafer manufacturing is highly desirable.
Join our team to contribute to innovative diagnostic solutions through precise manufacturing practices that uphold the highest standards of safety, quality, and efficiency!
Pay: $60,000.00 - $75,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Flexible spending account
- Health insurance
- Health savings account
- Paid time off
- Vision insurance
Application Question(s):
- Formulation of Buffers, Reagents for Diagnostics, GMP, Validation, Polymers, IVD, Wafers, Biochemistry
Education:
Experience:
- Chemistry, manufacturing & controls: 5 years (Required)
Ability to Commute:
- Santa Fe Springs, CA 90670 (Preferred)
Work Location: In person
