Formulation Scientist (R&D, small molecule)

Job Titles

  • Formulation/ Product Development Scientist
  • Formulation/ Product Development Chemist
  • Formulation/ Product Development Technologist

Educational Background

  • B.Sc.
  • M.Sc./ Ph.D. to be competitive
  • College diploma (entry level technician)

Job Function

  • Preformulation study
  • Development of a pharmaceutical dosage form

Preformulation study

  • Physicochemical characterization of the selected candidate molecule through both literature search and by coordinating with the R&D analytical lab and externals labs to get the data that are not available in the literature. Example:
    • Stability: Solid state (RH, oxygen, light, compatibility) and solution (pH, buffer, solvent, temperature)
    • Physico-chemical properties: solubility analysis, ionization/ pKa, partition coefficients, dissolution
    • Compatibility study: study of the compatibility of the candidate molecule with the excipients
    • Bulk properties: organoleptic, crystallinity and polymophism, powder flow, mixing and wettability, adhesion, particle size, shape and surface area, bulk density, hygroscopicity, compressibility

Formulation of a pharmaceutical dosage form

  • Select API supplier, review Drug Master File (DMF), ensure supplier has good reputation and all their API manufacturing is approved by regulatory agencies such as FDA and Health Canada
  • Make trial batches to develop a dosage form for an indication with the selected candidate drug molecule as the API. You will be using the data obtained during preformulation study.
  • Maintain good documentation practices as per Good Documentation Practices (GDP)
  • Write product development reports
  • Coordinate with analytical department for testing the trial batches and review the test results
  • Responsible for pilot plant scale-up
  • Work with Technical Services department during scale up for a successful transfer of the manufacturing process to produce large scale commercial batches
  • Work with Regulatory Affairs department (RA) to create and review documents for regulatory submission and provide needed data to RA department for regulatory submission
  • Perform gap analysis in order to prepare for any questions by the regulatory agencies

Must Have Skills

  • Strong writing, communication, interpersonal and presentation skills
  • Good understanding of formulation development steps and procedures
  • Theoretical knowledge of the manufacturing processes. Example: if working on formulating tablets, you should have good understanding of the tablet manufacturing processes such as dispensing, mixing, blending, granulation, drying, milling, compression, coating.
  • Knowledge of manufacturing process parameters.
  • Knowledge of chemicals and their physical and chemical properties.
  • Materials and polymers knowledge and pharmaceutical knowledge
  • Transparent and honest
  • Able to work in a environment with constantly changing priorities and meet deadlines
  • Able to work in a highly regulated environment and follow company Standard Operating Procedures (SOPs), regulatory guidelines and safety standards.
  • Knowledge of country’s regulatory agency (Health Canada for Canada), FDA (USA regulatory agency)) and ICH Guidelines
  • Understanding of Good Manufacturing Practices (GMP)

Type of companies that hire

  • Pharmaceutical
  • Biopharmaceutical
  • Biotech
  • Cosmetic Companies
  • Contract Labs
  • Cannabis Industry

Competitive Advantage

Competitive Advantage: a course/ certificate/ diploma on pharmaceutical product development

University graduates:

  • Detour to this position:
    • Formulation/ PD technician + a course/ certificate/ diploma on pharmaceutical product development
    • Manufacturing operator + a course/ certificate/ diploma on pharmaceutical product development and then apply to product development department

College graduates

  • if you don’t have a university degree but you have the relevant college diploma, you could get a Formulation/ Product Development Technician job. You will need a B.Sc. degree to grow further.

Career growth in this role

Technologist/ Chemist –> Senior/Scientist –> Group lead/ Supervisor –> Manager –> Director

Recommended Readings

ICH guidance Q8 Pharmaceutical Development