Symposium

The RNA Revolution

Elevate your research using gene expression
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RNAscope® Assay

Monthly Training Webinars, begining October 22, 2015

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Distribution of the c-MYC gene product in colorectal neoplasia.

AIMS:
Recent attempts to study MYC distribution in human samples have been confounded by a lack of agreement in immunohistochemical staining between antibodies targeting the N-terminal or C-terminal of the MYC protein. This aim of this study was to use a novel in situ hybridisation (ISH) approach to detect MYC mRNA in clinically relevant samples, and thereby determine the reliability of MYC targeting antibodies.

Expression of functional cannabinoid CB2 receptor in VTA dopamine neurons in rats.

We have recently reported the expression of functional cannabinoid CB2 receptors (CB2 Rs) in midbrain dopamine (DA) neurons in mice. However, little is known whether CB2 Rs are similarly expressed in rat brain because significant species differences in CB2 R structures and expression are found. In situ hybridization and immunohistochemical assays detected CB2 gene and receptors in DA neurons of the ventral tegmental area (VTA), which was up-regulated in cocaine self-administration rats.

Euglycemia Restoration by Central Leptin in Type 1 Diabetes Requires STAT3 Signaling but Not Fast-Acting Neurotransmitter Release.

Central leptin action is sufficient to restore euglycemia in insulinopenic type 1 diabetes (T1D); however, the underlying mechanism remains poorly understood. To examine the role of intracellular STAT3 pathways, we used LepRs/s mice with disrupted leptin-pSTAT3 signaling to test the effect of central leptin on euglycemia restoration. These mice developed STZ-induced T1D, which was surprisingly not associated with hyperglucagonemia, a typical manifestation in T1D.

Time-Dependent Decay of mRNA and Ribosomal RNA during Platelet Aging and Its Correlation with Translation Activity.

Previous investigations have indicated that RNAs are mostly present in the minor population of the youngest platelets, whereas translation in platelets could be biologically important. To attempt to solve this paradox, we studied changes in the RNA content of reticulated platelets, i.e., young cells brightly stained by thiazole orange (TObright), a fluorescent probe for RNAs. We provoked in mice strong thrombocytopenia followed by dramatic thrombocytosis characterized by a short period with a vast majority of reticulated platelets.

Social and novel contexts modify hippocampal CA2 representations of space.

The hippocampus supports a cognitive map of space and is critical for encoding declarative memory (who, what, when and where). Recent studies have implicated hippocampal subfield CA2 in social and contextual memory but how it does so remains unknown. Here we find that in adult male rats, presentation of a social stimulus (novel or familiar rat) or a novel object induces global remapping of place fields in CA2 with no effect on neuronal firing rate or immediate early gene expression. This remapping did not occur in CA1, suggesting this effect is specific for CA2.

Molecular Analysis of Sarcoidosis Granulomas Reveals Antimicrobial Targets.

Sarcoidosis is a granulomatous disease of unknown etiology. Prior molecular and immunologic studies have confirmed the presence of mycobacterial virulence factors, such as catalase peroxidase (katG) and superoxide dismutase A, within sarcoidosis granulomas. Molecular analysis of granulomas can identify targets of known antibiotics classes. Currently, major antibiotics are directed against DNA synthesis, protein synthesis, and cell wall formation.

Senior Manufacturing Process Scientist
Senior Manufacturing Process Scientist

We seek a highly creative and driven Manufacturing Support Scientist to join our Operations team. You will work within a highly dynamic group to serve as the technical resource for Manufacturing and Quality Control to transfer new products, trouble shoot reagent product problems, and scale-up Research Use Only (RUO) and in vitro diagnostic (IVD) reagents kits based on our RNAscope® technology.

2016 February 04

Education Experience

QUALIFICATIONS

MS/PhD in molecular biology, biochemistry, cell biology or related field with minimum 3 to 5 years of industry experience in IVD environment.

 

  • Expertise in molecular diagnostics design control process, product stability studies, validation and shipping testing, and setting product, process, and material specifications.

  • Experience in IVD product transfer and manufacturing in compliance with QSR and ISO quality systems.

  • Experience with documentation in support of IVD FDA 510(k)/PMA submissions and CE Mark/IVDD Technical Files/Dossiers.

  • Experience in conducting troubleshooting and non-conformity/CAPA investigation, supporting post-market surveillance & customer complaints, and working with RA and QA in resolving issues with regulatory agencies.

  • Experience in tissue/cell-based assays such as immunohistochemistry and in situ hybridization.

  • Excellent computer skills including Microsoft Excel and statistical data analysis programs such as Jump or Mini-tab.

Duties and Responsibilities

  • Manage the transfer of new products from R&D to Operations according to IVD and RUO Design Control processes.

  • Lead IVD process validation studies and document for regulatory FDA and IVDD/CE submission.

  • Provide IVD product information, data summaries and other required documentation to support FDA regulatory submissions/CE IVDD Technical Files and audit responses.

  • Identify and install new manufacturing equipment and testing instrumentation for meet scale-up goals, including generation of SOPs and training of operators.

  • Prepare or review manufacturing documents including DMR, SOPs, QC, specifications and templates.

  • Provide technical support to manufacturing and QC in the resolution of NCP, CAPA and Process Changes.

  • Evaluate current manufacturing process and provide technical advice for improvement.

Buyer
Buyer

We seek a highly motivated and energetic Inventory Buyer/Planner to join our Operations team.  A qualified candidate must be willing to learn new techniques quickly and be able to adapt to shifting priorities in a fast-paced and growing start-up environment.  We are seeking a detail oriented and organized Inventory Buyer/Planner to serve as our first point of contact for all supply chain needs.

2016 February 04

Education Experience

QUALIFICATIONS

  • B.A degree in a relevant field required.

 

•     3 to 5 years experience supply chain management.

•     Purchasing/Manufacturing/MRP experience in an ISO/QSR environment.

•     Previous experience with ERP Software System preferred.

•     Detailed knowledge of materials management, regulations, procedures, and records.

•     Experience in ISO 13485 and GMP environment required.

•     Strong team player and self-starter with the ability to work independently.

•     Strong organizational skills and attention to detail.

•     Proficiency with Microsoft Office.

•     Excellent verbal and written communication skills.

Duties and Responsibilities

Plan and execute procurement of materials and products.

•      Maintain strong working relationships and communications directly with the customer service, Manufacturing, QC, R&D, Planning and shipping to communicate lead times; coordinate manufacturing schedule and maintain inventory levels to ensure smooth supply flow.

•      Monitor purchase order status and shipment tracking information to ensure on-time deliveries.

•      Inventory Management: ensure appropriate inventory levels for all raw materials and finished products are maintained; maintain accurate transaction level detail of purchase orders in the ERP System; coordinate inventory planning and replenishment of raw materials, components, and finished goods.

•      Manage the company’s Supplier Management Program in accordance with approved procedures, including interfacing with suppliers, issuing SCARs as required, maintaining records for vendor qualification and status, providing metrics to monitor supplier performance

  • Follow company’s purchasing SOP and maintain good purchasing records.

Manufacturing Associate Scientist
Manufacturing Associate Scientist

We seek a highly motivated and dynamic individual to join our Operations team as a Manufacturing Associate Scientist.  An ideal candidate will be someone who is comfortable working in a fast-paced start-up environment, but who also has an understanding in delivering quality products to the market place. This person must be willing to learn new techniques quickly and be able to adapt to shifting priorities in a fast-paced and dynamic environment. This position will involve following established procedures and protocols to build and test reagent components for our RNAscope® Reagent Kits with minimal supervision. This position will also require the manufacturing of technically challenging products, which require a scientifically minded individual with can-do attitude. This position will also help in setting up new and improving existing procedures where needed.

2016 February 04

Education Experience

  • A B.S. within molecular biology, biochemistry, cell biology or related field with at least 2 years of industry experience
  • Must have demonstrated good biochemical laboratory skills
  • Must be able to work in cross functional team environments
  • Able to generate results and perform work with minimal supervision
  • Experience in molecular biology techniques, microscopy and imaging
  • Previous experience with ERP System preferred
  • Experience in ISO 13485 and GMP environment a plus
  • Candidate must be a strong team player, self-motivation and willing to learn new techniques and concepts in a fast paced environment
  • Strong organizational skills and attention to detail
  • Excellent verbal and written communication skills

Duties and Responsibilities

  • Formulate biochemical reagents precisely and efficiently according to manufacturing procedures
  • Generate and maintain manufacturing records to comply with Good Manufacturing Practices
  • Execute other associated processes related to the manufacturing of ACD reagent products
  • Assist in maintaining production and laboratory equipment
  • Build Custom RUO Products when needed

Occasional Duties and Responsibilities

  • May assist in process scale-up to transition from pilot lots to full production-scale manufacturing
  • May assist in transferring processes from development to manufacturing
  • Equipment monitoring and maintenance

  • Material ordering

  • Finish and fill activities where applicable

Manager Reagent Manufacturing
Manager Reagent Manufacturing

As the leader of ACD's reagent manufacturing team, plays a critical role in ACD's manufacturing operations. Ensures ACD's reagent products are produced in sufficient quantity and good quality to meet market demand. This position reports to Director of Operations.

2016 February 04

Education Experience

BS or MS in biology, biochemistry, chemical engineering or similar disciplines or equivalent work experiences.

Preferred Qualifications

  • Minimum of 5 years of relevant industry experience in reagent manufacturing companies.

  • Experience with ISO, QRS preferred.

Duties and Responsibilities

  • Coordinate with sales and marketing to establish a production schedule and plan for different reagent products.

  • Closely check the raw material and inventory levels and take necessary actions in procurement to ensure smooth reagent production.

  • Supervise day to day reagent production to satisfy market demand, ACD sales forecasts and internal R&D needs.

  • Work with QA/RA Department to establish, implement and maintain SOPs related to manufacturing operations.

  • Continuously monitor, maintain and improve the efficiency of ACD's production processes.

  • Monitor the operational conditions of facility and equipment used in production to ensure uninterrupted production.

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