Purpose
The ‘Formulation Chemist – II/Sr. Formulation Chemist’ is a key member of the R&D team who be responsible to ensure the formulation development & characterization activities for the assigned products are carried out in a timely manner as per organization needs. This would be a mid-level role who would be independently looking after assigned projects & ensure compliance to timelines as well as scientific & regulatory principles.
Position / Job Title
Formulation Chemist – II / Sr. Formulation Chemist
Department
FD – R&D
Reporting To
Sr. Manager – Research & Development
Location
Concord - Canada
Years of Experience
7 - 12 years
Dosage Form
Nasal / Liquid
Job Responsibilities / Deliverables
- Comprises of Formulation responsibilities including – preparation & characterization of lab scale formulation batches e.g., droplet size determinations, particle size determination, spray pattern, plume geometry, etc.
- Responsible for end to end product development from R&D to tech transfer
- Facilitate the transfer of lab scale developed formulations to manufacturing site
- Develop and implement comparability, stability, and in-vitro test methods to support regulatory submissions of nasal & inhalation products
- Conducting experiments based on scientific principles to develop formulations and designing manufacturing processes for various dosage forms including liquid (solution or suspension forms) for nasal and/or inhalation route.
- Prepare and review test methods, protocols, reports and standard operating procedures and train personnel as required.
- Analyzing data and writing reports, protocols, test methods, SOPs, and other documents.
- Documenting laboratory work in compliance with SOPs and cGMPs.
- Liaise with other cross functional department members including analytical, regulatory, supply chain, project management to facilitate project activities.
- Mentor junior chemists and lab assistants to ensure they conduct experiments in a compliant manner
- Support in regulatory documents preparation including development reports, correspondences
Qualifications & Pre-Requisites
- B.Sc. degree or equivalent in an applicable discipline of science (pharmaceutical sciences, chemistry, biochemistry, chemical engineering, medical laboratory science or related)
- 7 - 12 years of experience in a pharmaceutical R&D laboratory and / or CMO setting
- Experience in development of formulations in solutions/ semi-solids/ suspension dosage forms
- Experience in tech transfer and formulation development & characterization activities
- Exposure in development and characterization of nasal / inhalation products will be an asset Role requires independent working with minimal supervision.
- Candidate must be motivated and capable to handling independent projects
- Good written and oral communication skills
Additional notes
- Role may be required to work in afternoon shift (12 pm to 8 pm) on a need basis.
- Expected to travel overseas / within Canada on a need basis to manufacturing facility(ies) to participate in Technology transfer of products.
