Analytical Chemist
6 months ago
**Taro Pharmaceuticals Inc. **is a multinational, specialty pharmaceutical company with a vision of reaching people and touching lives globally as a leading provider of valued medicines. We are dedicated to meeting the needs of our customers and the overall community through the innovation, development, manufacturing and marketing of the highest quality healthcare products.
Established in 1950, Taro’s world class production facility is located in Brampton, Ontario, with a current team of over 600 Canadian employees. Our company’s focus on the dermatology sector has made us a leading manufacturer and supplier of specialized topical products with a diverse portfolio of creams, ointments, liquids, and gels.
With support from our parent company, Sun Pharma, one of the world’s largest specialty generic pharmaceutical companies, we are committed to providing a healthy, safe and rewarding environment for all of our employees.
What we offer:
A safe and clean; GMP regulated work environment
Opportunities for career growth and development
A competitive wage/salary
Employee training and organizational development programs, internal mobility programs, and employee recognition programs
Our Brampton location is presently looking for Analytical Chemist.
**Job purpose**
The main responsibilities of this position are to develop and qualify/validate bioanalytical and analytical procedures, test methods and provide analytical expertise required for the product development. Key duties include development and validation of new bioanalytical and analytical methods, preparation of reports, specifications and other documents for regulatory or legal submissions, with the emphasis on analysis of bioanalytical samples from in vitro bioequivalence screenings. Testing of other materials e.g. R&D/ Reference Products in accordance with GMP/GLP regulations may be required as needed. Work is completed with little supervision/guidance in a timely manner.
**Duties and responsibilities**
- Performs tissue separation, tape stripping, dermatome human skin, In Vitro permeation testing (IVPT) for topical formulations such as Creams, emulsions, lotions, serums, ointments, ophthalmic solutions.
- Develop, validate and document bioanalytical methods with minimum supervision.
- Preferred hands on experience of LCMSMS and HPLC.
- Performs data processing on Empower or Open lab.
- Prepare development/validation and other research reports
- Report and clearly document all research work performed
- Report GMP work in accordance with current GMP/GLP regulations adhering to ALCOA + Principles.
- Participate in activities leading to product approval (i.e. deficiency letter responses for chemistry issues, investigations, etc., with specific tasks outlined by the Manager)
- Provide technical and investigative support to R&D Analytical Chemists
- Participate in the training/coaching of new staff
- Isolate/identify/synthesize impurities as required
- Evaluate third party data, research reports, patents and publications for the technical content
- Research and prepare product and packaging material technical dossier/specifications
- Maintain a clean laboratory environment and ensure that safety regulations are followed
- Effective knowledge of chemistry, with main focus on analytical and bioanalytical analysis
- Hands-on experience with manual bioanalytical sample preparation and using automated solvent handler such as Hamilton instrument and MSMS modes
- Sound theoretical and practical knowledge of chromatography and spectrometry
- Hands-on experience on Water and Agilent instruments including both MS
- Effective knowledge of pertinent FDA, EMEA and TPP guidelines
- Good knowledge and understanding of GMP and GLPs requirements
- Ability to communicate and work effectively in an agile work environment
- Knowledge of applicable software
- Good organizational skills
- Multi-tasking and on-time delivery ability
- Excellent written and verbal communication skills
- Ability to learn new technologies
**Qualifications**
- Ph.D. or M. Sc. in Chemistry or in a pharmaceutical-related field
- Minimum one-year work experience for PhD and three years for M. Sc. in a bioanalytical environment.
- Superior theoretical and practical knowledge of organic, inorganic and analytical chemistry including in-depth knowledge of gas and liquid chromatography, spectrometry and other analytical techniques employed in the pharmaceutical development
- Exposure to in vitro bioanalytical testing such as IVRT and IVPT is highly preferred
- Ph.D. or M. Sc. in Chemistry or in a pharmaceutical-related field with minimum three years of work experience in an R&D environment, specifically in Dermatological Product Analytical Development and in-vitro technology
- Excellent logical skills required. Problems include both routine and non-routine tasks, such as chemistry related issues (i.e. understanding the degradation pathway of the active, dermal absorption/permeation); LCMS sample pr
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