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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.

Manufacturing Technician
Manufacturing Technician

We seek a highly motivated and energetic Manufacturing Technician to join our Operations team.  An ideal candidate will have some ISO and GMP experience, but be able to adapt to shifting priorities in a fast-paced and growing start-up environment. This position will involve following established procedures and protocols to fill, assemble and label sub-assemblies for kit components as well as building kits from sub-assemblies.

2016 February 04

Education Experience

  • Detail oriented, efficient and a team player

  • Able to multi-task and prioritize

  • Experience working in an ISO 13485

  • Previous manufacturing experience in biotech or pharmaceutical company is strongly desired

  • B.S. in Biological Sciences or A.A Degree is required

  • Excellent verbal and written communication skills

Preferred Qualifications

PHYSICAL REQUIREMENTS

This position requires lifting up 50 lbs, standing for long periods of time and carrying out repetitive tasks on a daily basis.

Duties and Responsibilities

  • Execute fill and finish job functions on a daily basis with minimal supervision

  • Assist in other areas of manufacturing deemed high priority such as special builds, bulk orders, inventory counts, or making of general use buffers etc.

  • Participate in general laboratory maintenance functions such as general cleaning of facility, cleaning of lab ware, changing of mats that are needed for normal manufacturing to occur

  • Place orders and organize manufacturing consumables

Occasional Duties and Responsibilities

  • Perform daily calibrations on key equipment

  • Participate in inventory counts

  • Perform some equipment maintenance; de-frost Freezers and Refrigerators, monthly cleaning etc.

Materials Manager
Materials Manager

We seek a highly motivated material manager to join our Operations team.  A qualified candidate is responsible to manage all aspects of materials flow and to maintain control and accuracy over all goods inventories, including all transactions, procurement, planning, scheduling, cost, warehouse, receiving, and shipping to ensure that customer orders are fulfilled on time. This position is also responsible to develop and manage all supplier relationships. 

2016 February 04

Education Experience

 

  • BS degree in business, management or other related discipline.

  • 5 years progressive experience in management of materials and sourcing within a design and manufacturing environment

  • Working knowledge and understanding of ERP/MRP systems in a manufacturing environment.

Preferred Qualifications

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

  • Experience in ISO 13485/QSR environment a plus

  • Strong organizational skills and attention to detail

  • Proficiency with Microsoft Office

  • Excellent verbal and written communication skills

Duties and Responsibilities

KEY RESPONSIBILITIES

  • Establish and implement methods and best practices related to the systems and process that support inventory forecasting, purchasing, and material control.

  • Develop and execute build to order and build to forecast plans based on commercial forecasts and other internal material usage. Work with manufacturing team for production planning.

  • Identify, develop and manage effective relationships with existing and potential suppliers of goods and services to meet the established cost, quality and delivery targets. Evaluate and review supplier qualification status on a regular basis.

  • Responsible for accuracy of inventory counts by implementing and managing, in conjunction with Finance, an inventory control system, capable of identifying discrepancies in inventory counts and taking corrective action to guard against inconsistencies in the future.

  • Plan and manage warehouse and storage capacity

  • Oversee Order Management group to make sure sales orders are timely processed.

A feed forward regulatory loop between androgen receptor and PlncRNA-1 promotes prostate cancer progression.

We previously reported that PlncRNA-1, a long non-coding RNA that is up-regulated in prostate cancer (Pca), affects the proliferation and apoptosis of PCa cells. However, the molecular mechanisms underlying these effects remain largely unknown. In this study, we demonstrated that long non-coding RNA PlncRNA-1, whose expression is promoted by Androgen Receptor (AR), protects AR from microRNA-mediated suppression in PCa cells.

Human liver chimeric mice as a new model of chronic hepatitis E virus infection and preclinical drug evaluation.

Abstract

BACKGROUND & AIMS:

Hepatitis E virus (HEV) is a major cause of acute hepatitis as well as chronic infection in immunocompromised individuals; however, in vivo infection models are limited. The aim of this study was to establish a small animal model to improve our understanding of HEV replication mechanisms and permit the development of effective therapeutics.

METHODS:

Differential Expression of Immune-Regulatory Genes Associated with PD-L1 Display in Melanoma: Implications for PD-1 Pathway Blockade.

Abstract

PURPOSE:

Blocking the immunosuppressive PD-1/PD-L1 pathway has antitumor activity in multiple cancer types, and PD-L1 expression on tumor cells and infiltrating myeloid cells correlates with the likelihood of response. We previously found that IFNG (interferon-gamma) was overexpressed by tumor-infiltrating lymphocytes in PD-L1(+) versus PD-L1(-) melanomas, creating adaptive immune resistance by promoting PD-L1 display. This study was undertaken to identify additional factors in the PD-L1(+) melanoma microenvironment coordinately contributing to immunosuppression.

Transit-amplifying cells orchestrate stem cell activity and tissue regeneration.

Transit-amplifying cells (TACs) are an early intermediate in tissue regeneration. Here, using hair follicles (HFs) as a paradigm, we show that emerging TACs constitute a signaling center that orchestrates tissue growth. Whereas primed stem cells (SCs) generate TACs, quiescent SCs only proliferate after TACs form and begin expressing Sonic Hedgehog (SHH). TAC generation is independent of autocrine SHH, but the TAC pool wanes if they can't produce SHH.

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