- Formulation/ Product Development Scientist
- Formulation/ Product Development Chemist
- Formulation/ Product Development Technologist
- M.Sc./ Ph.D. to be competitive
- College diploma (entry level technician)
- Preformulation study
- Development of a pharmaceutical dosage form
- 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
- Cosmetic Companies
- Contract Labs
- Cannabis Industry
Competitive Advantage: a course/ certificate/ diploma on pharmaceutical product development
- 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
- 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