Chosen candidate will be responsible for the formulation development of oral drug delivery products. Prior experience with transdermal products and/or oral film products is preferred. The chosen candidate will work with the formulations group on multiple projects and will drive technical innovation in formulation development. A thorough knowledge of chemistry, biochemistry, instrumentation and analytical methodologies is required. Experience in drug product manufacturing and technical transfer of drug product processes is preferred. Strong verbal communication and writing skills will be used to interface with representative, internal and external customers.
Some Essential Duties:
Formulation and process development of oral immediate-release dosage forms, including oral film formulations.
Design and execute formulation trials and evaluate stability data to finalize formulation composition.
Develop manufacturing processes for R&D formulations so that the technical transfer is successful for large scale batches.
Responsible for all formulation/ process related CMC documents which will be part of regulatory filings.
Write/review master formulas, manufacturing procedures, SOPs, stability protocols/reports, process validation protocols/reports, Product Development Reports, QOS, QbR etc.
Coordinate sourcing of APIs, excipients, packaging components for new products to meet regulatory requirements.
Perform formulation, physical and analytical testing as required.
Prepare/review specifications for drug products and packaging components, etc.
Coordinate the manufacturing of exhibit/submission batches per regulatory requirements
Perform technology transfer for manufacturing processes from laboratory scale to production scale.
Provide technical support during process validation and cleaning validation studies.
Coordinate with Analytical Method Development, Regulatory Affairs, Quality Control, Quality Assurance, Inventory Control, etc. to expedite the development and approval of new products by FDA.
Assure that all formulation and process development activities are documented as per company procedures and cGLPs.
Provide recommendations for continuous improvements in practices and systems to improve performance and enhance efficiency and quality.
Actively participate in obtaining patents for products, processes, or equipment.
Liaise with clients, suppliers, vendors and laboratories.
Min. 5 years work experience is mandatory
Recent experience in the pharmaceuticals industry is strongly preferred
Preference will be given to people who have recent experience in Pharmaceutical R&D with focus on drug delivery
PhD or master degree with a focus in Chemistry, Medicinal Chemistry, Pharmacy or Biochemistry
Thorough knowledge of the pharmaceutical industry, particularly oral drug delivery systems and the formulation and process development thereof
Knowledge of GMP regulations.
Skills building and maintaining productive relationships with organizational partners including team work
Excellent communication and writing skills in English and French