HudsonAlpha Institute for Biotechnology
  • 31-Aug-2017 to 30-Sep-2017 (CST)
  • Huntsville, AL, USA
  • Full Time
  • Diatherix

 

COMPANY OVERVIEW

Diatherix is an innovative, CLIA certified, molecular diagnostic laboratory utilizing proprietary TEM-PCR™ (Target Enriched Multiplex Polymerase Chain Reaction) technology for precise detection of infectious diseases – linking diagnostics to therapeutics.

Senior Production Specialist

Qualifications: Bachelor's degree in chemistry or biology with 5+ years' biotech manufacturing experience preferably in GMP or GLP environment. Previous laboratory experience required. Previous experience with single and multi-channel micro pipettes a must.

General Description: Main duties include reagent manufacturing for clinical laboratory, such as buffers, PCR reagents and others, reagent scale up, documentation of reagent preparations, reacting to results of reagent QC testing, troubleshooting, maintaining inventory, assisting in the revision and development of new production documents and ordering reagents and supplies for the GMP Production laboratory. The Senior Production Specialist is responsible for assisting in the transfer of newly developed projects from the R&D department. The Senior Specialist also assists in cost analysis, process improvements metrics, developing a weekly task schedule and preparation of monthly charge reports.

Specific Job Function requirements:

  • Assist the Supervisor in the planning and scheduling of the preparation of reagents for clinical laboratory
  • Familiarity with manufacturing of molecular grade buffer and reagents
  • Must have knowledge and experience with the use of pipettes, pH meters, stir plates, weighing and measuring in an aseptic laboratory environment
  • Nucleic acid extractions, measurement of nucleic acids concentration
  • Aliquoting small volumes using micro pipettes
  • Prepares and documents preparation of reagents
  • Ensures that reagent preparations performed according to approved procedures
  • Complies with Quality systems for reporting deviations
  • Assist the Production Supervisor with preparation of the Production department section of product batch records

 

  1. Reagent preparation activities include:
  • New oligo dilution preparation and aliquot
  • Primer mix preparation including supplementations
  • Control preparation
  • Nucleic Acid extractions
  • Proficiency testing sample preparation
  • Complex buffer and oligonucleotide mix preparation
  • Plasmids, bacterial cultivation and preparation
  • Chemical coupling procedure
  • Other reagent preparations as requested by the Production Supervisor
  1. Inventory Control: 
  • Maintains the CisPro inventory for the Production laboratory and reconciles it with physical inventory
  • Submits a weekly order requisition to the Production Supervisor for approval, then to the Purchasing Manager
  1. Other:
  • Oversees the reagent order fulfillment for on-site departments as well as regional laboratory sites
  • Ensures received raw materials and supplies meet required standards
  • Prepare SOPs and work instructions related to Production department
  • Participates in staff meetings to discuss progress and scheduling
  • Prepare monthly reagent charge reports for the clinical labs and send it to Production Supervisor for review
  • Assessment and incorporation of secondary raw material vendors
  • Prepares and packages product shipments
  • Cleaning and autoclaving of glassware and buffer carboys
  • Performs other duties as requested by the Production Manager
  1. Must be proficient using a computer and have experience and knowledge with Microsoft Office Suite
  • Document and excel spreadsheet editing skills required

 

For more information about Diatherix visit: www.diatherix.com

HudsonAlpha Institute for Biotechnology
  • Apply Now

  • * Fields Are Required

    What is your full name?

    How can we contact you?

    By clicking the button above, I agree to ApplicantPro's Applicant Information Use Policy.

  • Sign Up For Job Alerts!

  • Share this Page
  • Facebook Twitter LinkedIn Email
.
Logo About News Media Cafe Menu Careers Contact Smith Family Clinic Clinical facebook twitter flickr LinkedIn Research Sequencing Education Economic Development Support Collaborate Donate Our Founding Passion Leadership Events Careers Get in touch Directions Atrium Cafe