R&D Analytical Chemist (small molecule)

Job Title

  • R&D Analytical Chemist
  • R&D Analytical Scientist

Educational Background

  • Ph.D.
  • M.Sc.
  • B.Sc. (with industry lab experience)

Job Functions

  • There are 4 core responsibilities
    1. Method Development
    2. Method Validation
    3. Product Development Support
    4. Other duties

Method Development

  • Developing an analytical test method for testing a pharmaceutical dosage form or a raw material.
    • Example, developing an HPLC assay method or a viscosity test method.
  • Literature search
  • For HPLC test method, the following need to be determined/ selected:
    • solubility of the analyte, the right mobile phase and the HPLC column for the preferred chromatography, sample preparation method, HPLC conditions (injection volume, wavelength of detection, injection/run time, column temperature, sample temperature)
  • Performing trials to develop and finalize the method
  • Keep a detailed notebook of all the experimental procedures following good documentation practices (GDP) as per Good Manufacturing Practices (GMP). Note: GMP is the term used by Health Canada. CGMP (Current Good Manufacturing Practices) is the term used by FDA.
  • Write method development report
  • Meet the deadline

Method Validation

  • Validate the above developed method to ensure it is capable of doing what it claims to do (making sure the method can be used for it’s intended purpose). Validation conducted by following GMP and company Standard Operating Procedure (SOP)
    • For an HPLC method, validate the method by ensuring the developed method will pass all the following validation parameters: Precision, Specificity, Accuracy, Robustness, Linearity, Range, QL, DL (for impurity method).
  • Write method validation protocol and report
  • Any mistakes during validation will lead to writing a lab investigation report (LIR) involving the supervisor and the quality department.
  • Keep a detailed notebook of all the experimental procedures following good documentation practices (GDP) as per GMP
  • Meet the deadline

Product Development Support

  • At entry level, you will work with a scientist
  • Conduct compatibility study (excipient, packaging components). Write report.
  • Initiate experimental stability and test the samples. Write report
  • Test formulation development trial batches

Other test and duties as needed

  • Testing of stability samples and clinical samples, qualification of materials, investigation testing, testing a sample to respond to a question asked by a regulatory agency.
  • Technical Writing: Writing protocols, reports, test methods, standard operating procedures (SOPs)
  • Calibration/ verification/ maintaining of analytical instruments
  • Troubleshooting as needed
  • Order and receive chemicals and lab supplies

Must Have Skills

  • Knowledge of:
    • basic chemistry (e.g. pH, pKa, chemical bonds, acid/base, UV/Vis, density/ specific gravity, moles/ molarity/ molality)
    • High Performance Liquid Chromatography (HPLC) and how it is used to analyze samples quantitatively and qualitatively.
    • Good Manufacturing Practices (GMP), GDP (Good Documentation Practices as per GMP), WHIMS, Standard Operating Procedures (SOPs), Test Methods
  • Good at literature searching
  • Work well under pressure
  • Detail oriented and ability to follow written procedures without any deviation
  • Good documentation practices
  • Honest and transparent
  • Able to take responsibility for your own action
  • Work individually and as part of a team with different personalities
  • Professional, fast learner and takes initiative.
  • Able to work in a highly regulated environment and follow company Standard Operating Procedures (SOPs), regulatory guidelines and safety standards.
  • Able to present data to upper managements and to other departments in a meeting
  • Take initiative in continuous learning and being up to date with recent findings and changes in regulations by attending courses, seminar and/ or webinars

Type of Companies that hire

  • Pharmaceutical (small molecule)
  • Biopharmaceutical (bioanalytical)
  • Regulatory Agencies (Health Canada)
  • Biotech (bioanalytical)
  • Contract Labs
  • Cannabis Industry
  • Food Industry
  • Cosmetic companies
  • other

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