Purpose

To analyse R&D trial batches, Stability Samples and Routine calibration of the Instruments

Position / Job Title

Lab Assistant

Department

R&D

Reporting To

R&D Manager

Location

Concord - Canada

Years of Experience

0 to 1 year in Pharma

Dosage Form

Solid/Nasal/Liquid

Job Responsibilities / Deliverables:

• To analyse Assay, Preservative content, SAC, DSD, Osmolality, Viscosity and Spray pattern testing of R&D Trial batches samples, Stability samples and Stability report preparation.
• Particulate matter method development and R&D Trial batch analysis by APSS, PSD method development by Microscope and Viscosity method development.
• Cleaning method development and partial validation.
• Partial validation of Assay, Preservative content methods.
• Reverse engineering study, Tubing study analysis, PDR batches analysis
• To perform Chemical testing and Method evaluation for API
• Daily Balance calibration, pH meter calibration,
  
  
  
  Actuator movement verification / Load cell calibration of Proveris and Malvern system.
• Development STP, Specification and Development Stability Protocol and report preparation
• Controlled substance sample destruction on weekly basis

Qualifications & Pre-Requisites:

• Master of Science Degree in a chemistry or related field, combined with minimum 0-1 year of pharmaceutical industry experience in a laboratory / GMP setting.
• Knowledge of Health Canada and U.S. FDA GMP requirements for pharmaceutical testing, the Controlled Drugs and Substances Regulations and the Precursor Control Regulations would be an asset.
• Valuable working knowledge of Microsoft Office programs, especially Excel and Word.

Additional notes:

• Receiving, inventorying, labeling and disposing of samples requires some reaching/bending and light lifting on a daily basis.
• Flexibility in hours of work to address emergency issues / controlled substance related activities outside of normal workday.