The ODAN Advantage:
- Growing specialty pharmaceutical company
- Group Insurance plan, with Dental and LTD Benefits
- Onsite free parking
- Friendly work environment
We are looking for candidates who are engaged and want to make a difference!
R&D Analytical Chemist - ODAN LABORATORIES LTD.
Founded in 1974 in Montreal, Canada. Odan Laboratories is a 100% Canadian Specialty Pharmaceutical Company. Fully integrated infrastructures for R&D, manufacturing, distribution, and marketing. Our vast Product line includes innovative products in gastroenterology, dermatology, and various specialty and generic pharmaceuticals. Odan products are distributed to retail pharmacies, hospitals, government institutions, clinics, and pharmaceutical wholesalers. Our products are also exported to several countries around the world. Odan is continuously researching and developing new pharmaceutical molecules and adding to its portfolio.
Job summary:
Reporting to the R&D Manager, the R&D Analytical Scientists are responsible to provide analytical support during entire new drug product development process, from DMF (drug master file) investigation, analytical method development and validation, fast track analysis of raw material and finished products, to analytical document preparation for new drug product submission.
Job Responsibilities:
- Perform analysis of raw materials, finished products and stability samples following compendia or in-house testing methods using analytical instruments. Compile all data obtained from testing and observations and completes report summaries, as per established SOPs
- Prepare analytical documents such as analytical methods, method validation protocol, method validation report and various investigation reports in accordance with regulatory requirements.
- Recognizes OOS or OT results and under the direction of the supervisor assists in the completion of lab investigation. Optimize and trouble shoot analytical methods when issues encountered during routine QC testing.
- Develop and validate analytical methods following cGMP guidance documents of different regulatory agencies (Health Canada, USFDA…)
- Coordinate with external contract laboratories for both API and finished products
- Perform lab equipment maintenance
- Maintain various inventories of R&D team such as chemical reagents, reference standard, columns, etc.
- Maintains compliance to all health and safety standards, GMP, GLP and regulatory requirements.
- Work as effective team member to meet departmental and corporate goals, sharing information and knowledge with team members and across organization.
- Perform additional related duties as assigned by manager.
Desired Skills and Experience:
- 1 to 5 years working experience in pharmaceutical industry.
- Hand on experience on HPLC, GC, UV, FT-IR and wet chemistry
- Knowledge of cGMP/GLP, USP, EP/BP, ICH, FDA and OHSA guidelines applicable to laboratory and product development
- Able to troubleshoot analytical methods and laboratory instrumentation
- Time management skill and able to work under pressure
- Excellent verbal and written communication skills
- Knowledge of Microsoft Word and Microsoft Excel
Education:
B.Sc. / M.Sc from a recognized educational institution in Chemistry or a related field; relevant experience in the analysis of semi solids and liquids pharmaceutical products.
Job Type: Full-time
Benefits:
- Company events
- Dental care
- Disability insurance
- Extended health care
- Life insurance
- On-site parking
- Vision care
Work Location: In person
