Posted on Feb 20, 2021 by Universal Sequencing Technology Corporation
Location: Carlsbad, CA
Universal Sequencing Technology, a biotech startup headquartered in Canton, MA (~15 miles southwest of Boston) with a location in Carlsbad, CA, is looking for a highly talented Manufacturing Scientist to join the team, located in Carlsbad, CA.* We are excited to provide novel DNA sequencing technology for the Next Generation Sequencing (NGS) platforms that enables many previously unachievable applications. This position is a unique opportunity to commercialize a novel NGS library technology, TELL-Seq TM , an ultra-low input single tube linked read technology which enables many previously unachievable long read applications and to develop disruptive single cell applications.
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.
- 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
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