Formulation Chemist II

PurposeThe ‘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 TitleFormulation Chemist – II / Sr. Formulation ChemistDepartmentFD – R&DReporting ToSr. Manager – Research & DevelopmentLocationConcord - CanadaYears of Experience7 - 12 yearsDosage FormNasal / LiquidJob Responsibilities / DeliverablesComprises 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 transferFacilitate 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 productsConducting 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 mannerSupport in regulatory documents preparation including development reports, correspondencesQualifications & Pre-RequisitesB.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 settingExperience in development of formulations in solutions/ semi-solids/ suspension dosage formsExperience in tech transfer and formulation development & characterization activitiesExposure 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 skillsAdditional notesRole 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.