Medipure’s mission is to revolutionize drug discovery and bring innovative and safe medication for the treatment of pain, anxiety and skin disorders. We bring novel prescription medicines to market, providing patients with serious conditions valuable solutions that improve quality of life through the development of safe and effective endocannabinoid-based therapeutics.
Through rapid cost-effective product development, by addressing market needs, and establishing strategic partnerships, we seek to maximize the value of our products and provide innovative treatments for targeted diseases. For information, please visit our website.
Position: Formulation Scientist
Reports to (Position): Chief Technical Officer (CTO) and R&D Management
Department/ Section: Research and Development
Principle Account abilities
Reporting to the CTO and R&D Management the incumbent is responsible for developing, optimizing and up-scaling the drug formulations for various R&D clinical trial projects ensuring they adhere to FDA, EMA, and Health Canada requirements for safety, efficiency and quality. The Formulation Scientist will support R&D projects by conducting formulation development, evaluation, analytical characterization, and technology transfer to scientists involved in clinical manufacturing activities.
- Develop infrastructure for analysis and execution of pre-formulation and formulation research activities.
- Plan, develop, and implement scientifically well-designed experiments with minimal direction and guidance.
- Co-ordinate with other R&D Departments to understand the needs and develop new technologies.
- Develop novel, safe and effective oral solid dosage formulations and transdermal/topical formulations for clinical trials and commercial use, such as tablets, capsule, creams/lotions, oral dissolvable films, and transdermal films.
- Support R&D activities related to novel drug delivery system.
- Identify the multidimensional aspects of complex problems and applies novel and creative solutions to problems.
- Develop, set-up, scale-up and optimize formulations, and manufacturing processes in a GMP environment. Optimize formulation and process through QbD approach.
- Identify critical process parameters and process control for scaling up the manufacturing process and transfers the technology accurately to the Manufacturing Department.
- Compile and prepares professional technical reports, and CMC documents for clinical trial applications (FDA, EMA and Health Canada).
- Support Manufacturing Department during equipment purchase/set up, testing (raw/intermediate/finished products), technology transfer, process optimization, upscaling and pilot batch production.
- Participate in investigations into product failure. Ensure involvement in all trouble-shooting activities.
- Perform short- and long-term stability studies.
- Comply with GMP’s SOP’s and all regulatory documentation. Follow ICH, FDA, EMA, and Health Canada guidelines for product development under GLP/GMP conditions.
- All other duties as assigned.
Qualifications and desired skills:
- Master’s or Ph.D. Degree in chemistry, Chemical Engineering, Pharmaceutical Sciences or equivalent.
- Hands-on expertise in formulation development for solid oral dosage and/or lipids/polymer/nanoparticle-based sustained drug delivery.
- Skilled in drug delivery optimization, using DOE where applicable.
- Experience with handling of a controlled substance is desired.
- Thorough cGMP, and GLP knowledge is a must. Knowledge of Health Canada’s CDSA and quality guidelines to formulate compliant products is an asset.
- Knowledge of FDA regulatory guidance’s, ICH guidelines and requirements of clinical trial applications are a must.
- Minimum 7-10 years of formulation experience in both lab and clean room environment.
- Working knowledge of patents, pharmacokinetics and biopharmaceutics.
- Ability to communicate effectively with multiple departments and levels within the organization.
- Strong ability to coordinate multiple projects and priorities and work well under time constraints.
- Technical ability to trouble shoot as required.
- Excellent verbal and written communication skills.
- Must be flexible, a strong team player, excellent attention to detail and have a hands-on approach.
If you want to further develop your skills and build a long-term career with a growing company – Apply Today!
About the Benefits
Upon joining Medipure you will be welcomed into a dynamic and multicultural team. In exchange for your hard work and dedication, you will receive a competitive annual salary plus a comprehensive benefits package.
And that's not all! When you join Medipure, you will have the ability to define your own career path while working with an engaged and excited team.