Senior Scientist - Immunoassay Manufacturing - Maryland United States - 37252



JOB DESCRIPTION

Job #: 37252
Title: Senior Scientist - Immunoassay Manufacturing
Job Location: , Maryland - United States
Employment Type:
Salary: $90,000.00 - $140,000.00 - US Dollars - Yearly
Employer Will Recruit From: Nationwide
Relocation Paid?: Yes

WHY IS THIS A GREAT OPPORTUNITY?


This company is a proud subsidiary of an Australian Headquartered Biotechnology/Diagnostics leader, with a landmark project to build USA manufacturing capability - fully funded via a Department of Defence strategic investment.

They are a Health Technology company that develops and manufactures rapid and accurate digital diagnostics for U.S. medical practitioners and consumers. 

They achieve this by applying the working practices of our parent organisation through the integration of next-generation diagnostics, reader technology and software. 

Their products are distinguished by their simplicity of use, rapid time to result and connectivity. 

The Vision:

A world where people return to health as soon as possible.

The Mission:

Through the creation of simple, accurate diagnostic tools and through the linking of the results of those tools to the best treatment, we help people to get better sooner and enjoy their lives.

The Purpose:

To create rapid, accurate diagnostic tools that link people to optimal therapy.

JOB DESCRIPTION

The Senior Scientist – Assay, will be working as part of the multidisciplinary production team by assisting the manufacture of Assay components.  These include, but not limited to, Lateral Flow materials, testing writing and reviewing documents, and completing batch records whilst complying to Good Manufacturing Practice (GMP).  The role will be required to set-up, operate and maintain the equipment involved in the manufacture of Assay components used in Lateral Flow production. 

The role will be responsible to prepare and maintain the buffer / solution stocks required for manufacturing and will actively take part in general housekeeping of the laboratory day to day tasks.  The Senior Scientist – Assay will be required to effectively communicate with other departments to meet organisational production forecasts. 

 

Duties and Responsibilities

  • Manufacture the Lateral Flow Assay components according to GMP.
  • Assist with the sourcing, installation, and validation of equipment required for upscaling Lateral Flow Assay manufacture.
  • Co-ordinate upscaling of Lateral Flow Assay manufacture to meet future production demands.
  • Contribute to the development and verification of diagnostic immunoassays that will be integrated into handheld medical devices for clinical studies.
  • Complete manufacturing documents according to GMP requirements.
  • Create, amend and review manufacturing document as required.
  • Supervise and oversee assay scientist activities, setup, operate and maintain equipment, fill out logs where applicable.
  • Identify, report and troubleshoot problems with equipment.
  • Prepare and maintain stocks and buffers and solutions required in manufacturing to a GMP standard.
  • General housekeeping of the laboratory. 

QUALIFICATIONS

QUALIFICATIONS

Essential:

  • Bachelor of Science
  • At least 5 years of experience in a GMP manufacturing environment
  • Experience with Quality Management Systems

EXPERIENCE & SKILLS

Essential:

  • Previous upscaling experience of manufacturing processes.
  • Previous lateral flow or ELISA manufacturing experience.
  • Good motor skills and the ability to do fine and repetitive tasks.
  • Ability to read and carefully follow instructions.
  • Excellent attention to details and good organisational skills
  • Capable of working independently to a schedule.
  • Ability to operate general lab-based equipment.
  • Strong sense of urgency.
  • Excellent with general house-keeping of lab-based tasks.
  • Strong Interpersonal skills.
  • Excellent written and verbal communication skills.
  • Ability to identify defects in materials and processes.
  • Competency in Microsoft applications including Word, Excel, and efficient use of email.

Desirable (but not essential):

  • Proven record of developing immunoassays on different immunoassay platforms.

Education:
University - Bachelor's Degree/3-4 Year Degree

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