Job Description

Job Function:

• Comprises Formulation Responsibilities
• Preparation and characterization of lab-scale formulation batches.
• Develop and implement comparability, stability, and in-vitro test methods.
• Perform In-vitro bioequivalence testing to support regulatory submissions of products
• Responsible for providing technical input to Technical Project Team for development programs
• Responsible to provide guidance, training, and mentorship to other chemists

Duties and Responsibilities:

• Assisting in the formulation development of inhalation and nasal products
• Provide scientific inputs to address challenges during product development
• Conducting experiments to develop formulations and designing manufacturing processes for solution and suspension dosage forms
• Liaise with cross-functional team members including analytical, QA, and regulatory and ensure execution of project activities as per timelines and priorities
• Assisting in the development and qualification of test methods for nasal characterization.
• Testing of physical parameters (e.g., droplet size determinations, particle size determination, spray pattern, plume geometry, etc.) for formulated and brand leader products for laboratory-scale batches and stability studies
• Assist with the preparation of documents such as study protocols, reports, and regulatory communications.
• Evaluate and summarize the results of product development studies.
• Perform specification development and release testing of finished products and device components
• Prepare and review test methods, protocols, reports, and standard operating procedures and train personnel as required.
• Prepare pharmaceutical development reports
• Analyzing data and writing reports, protocols, test methods, SOPs, and other documents.
• Participate in equipment qualification and calibration as per schedule
• Documenting laboratory work in compliance with SOPs and cGMPs.
• Maintaining a safe work environment
• Any other duties as assigned

Skills and Qualifications:

• Advanced degree in an applicable discipline of science (pharmaceutical sciences, chemistry, chemical engineering, or related)
• 7 - 10 years of experience in a pharmaceutical R&D laboratory and/or CMO setting
• Experience in the development of formulations in solutions, semi-solids, and suspension forms
• Experience in the development and characterization of nasal products will be an asset
• Great attitude and motivated to learn new skills
• Good written and oral communication skills.

Job Type: Full-timePay: $50,564.72-$600,000.00 per yearBenefits:

• Dental care
• Extended health care
• Life insurance

Schedule:

• Day shift

Ability to commute/relocate:

• Concord, ON: reliably commute or plan to relocate before starting work (required)

Education:

• Bachelor's Degree (preferred)

Experience:

• Formulation Chemist: 3 years (required)
• formulation development of inhalation and nasal: 2 years (preferred)