Medical Device Company jobs in Cambridge, ON

ABOUT SPA DENT

Founded in 2009, Spa Dent is a manufacturer of gels, liquids, pastes and medical devices. We specialize in high efficacy, natural wellness Oral Care, Antibacterial Soaps, Medicated shampoos and Lotions.

Spa Dent offers our healthcare products through Dental and Retail channels in North America, Europe, Asia and the Middle East, both Branded and Private Label. Our products meet the standards required for Medical, Dental and Retail channels globally.

Head office and manufacturing facilities located in Cambridge, ON Canada. Licenses include Health Canada NHP & Class 1 MDEL site licenses and FDA Drug Establishment & MDEL site registrations. We are a socially responsible company and are 3rd party audited.

If you are looking to join a growing pharma company that truly cares about its employees and customers, we invite you to take your next step forward with Spa Dent.

DESCRIPTION

The R&D Special Projects Team Lead is responsible for formulation research & development, the transferring of new formulas to production, the generation of production paperwork, and communicating with other departments to ensure new projects are being completed appropriately. They will work closely with other members of the R&D lab, Quality and Regulatory Managers, to enhance SRED, IRAP and customer project tracking and reporting.

RESPONSIBILITIES

• Formulation Research & Development.
• Coordinate with sales department regarding development projects, formulate based on customer demands. Attend meetings and answer any relevant customer questions.
• Work with Quality Assurance on performing investigations into facility compliance, bulk and finished product testing, and stability data.
• Oversee/Manage the stability program, including scheduling internal and external testing, creation of the stability calendar, coordination of testing personnel, writing and/or review of the final stability reports, and other duties as necessary.
• Complete change control forms as appropriate, following quality management systems.
• Generate production documents, including formula sheets, batching instructions, COAs for new products.
• Method development and validation for new analytical test methods, assays, raw material release, etc.
• Supervise first productions, work with compounding team to find improvements in manufacturing instructions and revise paperwork to incorporate improvements.
• Provide new formulas as approved to the production manager as necessary
• Assign new product numbers and raw material numbers as necessary
• Create and manage R&D meeting notes. Coordinate weekly meetings with Sales, QA, and ownership
• Review and approve newly developed formulas. Ensure the formulas are chemically stable.
• Manage costing of all new formulas
• Ensure lab inventory is maintained and any replacement materials or glassware are ordered in a timely manner
• Manage relationships with suppliers over email and phone calls. Know who supplies each material.
• Attend educational and networking events as appropriate
• Manage new projects and coordinate with customers as appropriate
• Documenting and keeping detailed records of test results, specifications, stability studies and procedures in a standard professional format.
• Documenting and keeping detailed records of materials consumed, and time devoted to SRED, IRAP, and customer projects.
• Writing and / or assisting in writing detailed reports for SRED, IRAP and other purposes that may arise.
• Manage multiple projects and competing priorities.
• Timely communication of all information regarding formulation, project status, costing, results, etc. to all appropriate individuals respecting the confidential nature of the project.
• Troubleshooting formulation and scale-up issues.
• Understand each ingredient function and its use.
• Assist QAP in label review and complaint investigation process, raw material and finished product release.
• Aid in stability testing as necessary and monitor results of formulas in the development stage. Conduct physical, chemical and organoleptic testing; makes oral and written observations and judgments on process and outcome to provide feedback, perform troubleshooting on unstable formulas.
• Reviewing and/or developing specifications for new products for suitability with existing manufacturing systems and feasibility of other advanced technologies.
• Perform all the applicable analytical testing based on product’s specifications and written procedures.
• Understand Regulatory requirements for formulations.
• Create SDS sheets for newly developed products.
• Maintain facility SDS, ensure documents are current and that new materials brought into the facility are added.
• Maintain chemical inventory of lab.
• Must adhere to safety standards.
• Required to perform other duties as assigned.

EDUCATION AND EXPERIENCE

• Bachelor’s degree in Chemistry.
• Experience in formulating personal care projects.
• Knowledge of development of formulations using natural ingredients.
• Report writing experience.
• Experience with SRED, IRAP and other government funding programs.
• Detailed knowledge and experience with various lab equipment, lab processes and procedures.
• Familiar with ISO and NHP-GMP, OTC production standards and requirements.
• Understanding of Health Canada Cosmetic & NHP, FDA Medical Device, OTC and Cosmetic regulations.
• Strong communication skills along with the ability to interact effectively with frontline employees, peers, and executives.

We thank all applicants, however only those selected for an interview will be contacted.

Pay: $26.00-$30.00 per hour

Expected hours: 37.5 per week

Benefits:

• Dental care
• Extended health care
• Vision care

Work Location: In person