Diagnostic Product Production Analyst - Pinetown, South Africa - NBISA Recruitment

NBISA Recruitment
NBISA Recruitment
Verified Company
Pinetown, South Africa

1 month ago

Thabo Mthembu

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Thabo Mthembu

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Job Advert Summary:

To use as an individual, his/her academic background, training and experience to perform immunoassay, protein expression and purifications prescribed for the production and QC analysis of saleable monoclonal antibodies, recombinant antigens, ELISA kits and components.

Key results areas:

  • QC testing of ELISA reagents, components and final kits
  • Recombinant Antigen Production and quality analysis
  • QC analysis of NBI saleable monoclonal antibodies
  • Laboratory resourcing and equipment maintenance

Minimum Requirements:

  • Essential: BSc in Biochemistry, Microbiology
  • Preferred: BSc Honours in Biochemistry, Microbiology
  • 23 years ELISA experience and
  • 23 years recombinant protein expression and purification experience

Duties and Responsibilities:

QC testing of ELISA reagents, components and final kits.

  • QC testing of all ELISA reagents, components and final kits during the different production stags.
  • Perform QC procedures on the following ELISA components:
  • EPU Coated ELISA plates
  • Inprocess testing on the hyperimmune
coated plates.

  • Hyperimmune conjugates
  • All ELISA components (2% Bosine,
Conjugate Diluent, Sulphuric acid,

Chromogenic substrate, Controls and


  • Complete documentation for all kit components, upload results into LIMS and send to QARM analyst for signing off and authorization in LIMS and final release in SAP.
  • Complete documentation for final kits and upload into SAP, send to QARM analyst for SAP upload and to Head: DPP for SAP authorization and to internal Auditor for review and Head: QA for final release of the ELISA kits in SAP.
  • Perform test and method validations according to internal DPP program.
  • Trouble shooting of hyperimmune ELISA kits for QARM to resolve quality issues.

Production and QC testing of recombinant antigens associated with saleable monoclonal antibodies

  • Produce recombinant proteins to support monoclonal antibody production of saleable antibodies.
  • QC test to validate activity, specificity and coating concentration of produced recombinant antigens

QC analysis of NBI saleable monoclonal antibodies

  • Perform QC analysis on purified saleable monoclonal antibodies using sdspage gel electrophoresis and determine the antibody purity by densitometric analysis using gel imaging software.
  • Provide mAb purity and gel result documentation to

Section Head:
Antibody Production to complete final release of NBI monoclonal antibodies.

Laboratory resourcing and equipment maintenance

  • Maintain laboratory equipment and cleanliness
  • Maintain chemical and operational consumable stock levels.
  • Ensure compliance with ISO13485 standards.
  • Perform the general housekeeping of the laboratory.

Core Competencies

  • Managing Relationships
  • Personal Leadership
  • Business Impact
  • Leading and Influencing others Technical/Professional knowledge and proficiency
  • Knowledge of ISO13485 quality system
  • Technical/Professional knowledge and proficiency
  • Planning and organising
  • Attention to Detail and analysis
  • Written and verbal communication
  • Computer Literacy in MS Office, SAP and LIMS
  • Experience in immunoassays, design and troubleshooting ELISA's
  • Collaboration and teamwork

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