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Assay Manufacturing Lab Technician

  • Dynex Technologies, Inc.
  • Chantilly, VA, USA
  • Jul 01, 2020

Job Description

Job Title: Assay Manufacturing Lab Technician - 2 positions.

Job Summary: This is a position where the incumbent will be responsible for manufacturing under ISO 13485 and cGMP environment. Products that will be manufactured in this group will be reagents and consumables that utilize Dynex Multiplier bead technology.

Essential Functions:

Complete tasks scheduled by the Supervisor. Must demonstrate a flexible and organized approach to maintain the schedule with the flexibility to reorganize in the event of unexpected changes. Meticulously follow all Operating Procedures, OSHA and internal Dynex safety procedures related to all assigned tasks and accurately complete all associated paper or electronic records.

Core duties include, but are not limited to:

  • Verify and maintain laboratory equipment according to defined daily/weekly or monthly schedules.
  • Daily replenishment of stocks of consumable laboratory items, count and sort raw material and laboratory stock as required.
  • Clean laboratory glass and plastic ware, and ensure it is kept safe and organized.
  • General cleaning and maintenance duties.
  • Make buffers.
  • Prepare serum for calibrators, controls, QC panel and testing purposes: to include conversion from plasma, filtration, preservation and aliquoting.
  • Prepare beaded and bagged plates using previously coated beads.
  • Dispense and label liquid components.
  • Routine inspection of incoming raw materials.
  • Make and test liquid components (pre-diluted calibrators, controls & conjugate, SD, WB and QC fluids).
  • Coat and test beads.
  • Design Multiplier assay plans and protocols to achieve fixed criteria, run the assays and analyze the data using Excel spreadsheets.
  • Completion of quality record, to include assessment of results against fixed criteria or experimental aim.

Supervisory Responsibilities: None.

Success Factors:

  • Consistently completes essential job functions within the agreed upon timelines.
  • Exactly follows the required Operating Procedures with a high degree of technical accuracy and attention to detail.
  • Able to work to a high standard with minimal supervision and demonstrates a good level of understanding of all tasks completed.
  • Open and honest communication, both written and verbal.
  • Clear evidence of self-motivation and engagement, such that all tasks are completed accurately.
  • Perform basic second person checks with high accuracy.
  • Design valid assay plans according to fixed criteria.
  • Independently and accurately process standard assay data.
  • Complete all task associated quality records, including the assessment of results against fixed criteria or against a pre-defined experimental aim.

Minimum Qualifications/Education: Bachelors or Master degree in Chemistry, Biology, Biochemistry or related scientific discipline. This position requires a minimum of 2 years' experience in commercial reagent/assay production.

Computer Skills: Use of LIMS or other ERP system in a manufacturing environment. Proficient in MS Office.

Work Environment: Manufacturing laboratory and office.

DYNEX Technologies, Inc. is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, including sexual orientation and gender identity, national origin, disability, protected Veteran status, or any other characteristic protected by applicable federal, state, or local law. DYNEX Technologies provides medical, dental, life and disability insurance, Section 125, 401(k), flexible schedules, educational assistance and a great work environment!

To apply, please click the below link:

https://recruiting.paylocity.com/recruiting/jobs/All/c7607535-18ba-4fab-b961-c2f9d9661fef/Dynex-Technologies

Visit our website www.dynextechnologies.com.


Success Factors:

  • Consistently completes essential job functions within the agreed upon timelines.
  • Exactly follows the required Operating Procedures with a high degree of technical accuracy and attention to detail.
  • Able to work to a high standard with minimal supervision and demonstrates a good level of understanding of all tasks completed.
  • Open and honest communication, both written and verbal.
  • Clear evidence of self-motivation and engagement, such that all tasks are completed accurately.
  • Perform basic second person checks with high accuracy.
  • Design valid assay plans according to fixed criteria.
  • Independently and accurately process standard assay data.
  • Complete all task associated quality records, including the assessment of results against fixed criteria or against a pre-defined experimental aim.

Minimum Qualifications/Education: Bachelors or Master degree in Chemistry, Biology, Biochemistry or related scientific discipline. This position requires a minimum of 2 years' experience in commercial reagent/assay production.

Computer Skills: Use of LIMS or other ERP system in a manufacturing environment. Proficient in MS Office.


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