Location: Carlsbad, CA
The incumbent will have hands on experience on DNA conjugation and amplification, in-process quality control assay development, filling and labeling experience and capability to increase scalability using technology, equipment, manpower, etc... to meet increasing demand. S/He will work closely with R&D and manufacturing teams to scale up production procedure and accelerate product commercialization. S/He must have excellent documentation skills and strong interpersonal skills, be driven by making high quality products, and enjoy working in a multi-disciplinary environment.
Key Responsibilities- Engineer scale up procedures for bulk production, filling process and kit assembly
- Optimize reagent formulation and process for bulk DNA amplification in emulsions
- Develop in-process quality control assays (analytical) for reagent formulations, productions, characterization and identification
- Execute well thought out experiments, record results accurately along with in-depth analysis and reports that will be reviewed, approved and filed in QA
- Create/update manufacturing production protocols, execute protocol and/or train others to do the same
- Work with other manufacturing personnel to make bulks, fill reagents and assemble kits. This is a hands on, in the lab position
- Work with Inventory Management to ensure proper handling, storage, usage and accountability of all materials needed to produce or test products
- Manage and execute stability sampling, storage and testing
- Manage tasks, projects and timeline to meet deliverable on time and on quality. Manage resources accordingly for the same
- Write, review and revise SOP's through a Document Change Order.
- Initiates, Investigates and write up non-conformance reports.
Required Skills and Background- M.Sc. or Ph.D. in chemistry, chemical engineering, molecular biology, biochemistry, biology, biotechnology or a similar field (B.S. with exceptional experience WILL be considered)
- Prior GMP and GDP experience is required.
- Hands on experience with magnetic beads (suspension material), oligo conjugation and quantification
- Direct experience in nucleic acid amplification technologies, particularly in emulsion PCR
- Experience in Lean Six Sigma project implementation is a plus
- 5-7 years experience in a reagent GMP environment
- Detail oriented and very good documentation skill
- Hands on leaders perform well in this environment
