Job Information
Sun Pharmaceuticals, Inc Senior Analytical Chemist in Canada
Job purpose
The main responsibilities of this position are to develop and validate analytical test methods and provide analytical support to product development chemists. Key duties include development and validation of new analytical methods, preparation of protocols and reports, and other documents for regulatory submissions. Testing of R&D batches, raw materials and packaging components in accordance with GMP/GLP regulations may be required as needed. Work is completed with little supervision/guidance in a timely manner. Participate in the training/coaching of new staff.
Duties and responsibilities
Perform testing using advanced GC/HPLC techniques as well as specialized testing using particle size analysis and other techniques as required
Develop, validate and document new analytical methods with minimum supervision.
Independently prepare method validation protocols, method development and method validation reports
Research and prepare drug product and drug substance specifications
Perform compendial method verifications and validations as per protocol
Perform testing of R&D products and raw materials as per specifications
Participate in activities leading to product approval under the guidance of Senior R&D staff (ie. deficiency letter responses for chemistry issues, investigations, etc.)
Function as the Analytical Project Lead for select development projects.
Conduct laboratory investigation activities (OOS, laboratory incidents etc.)
Report and clearly document all research work performed
Report GMP work in accordance with current GMP/GLP regulations
Initiate and follow through with actions required for change controls
Complete Corrective and Preventative Actions (CAPAs)
Participate in the training of new staff
Maintain a clean laboratory environment and ensure that safety regulations are followed
Complete all training assignment and maintain personal training records.
Flexibility to work shift schedules when required
Other duties as assigned
Qualifications
B. Sc. in Chemistry or related pharmaceutical discipline
Minimum five (5) years of relevant experience in a pharmaceutical environment.
In In-depth knowledge of gas and liquid chromatography, spectroscopy and other analytical techniques employed in the pharmaceutical development
Sound knowledge of chemistry, with main focus on analytical, organic and physical chemistry
Excellent knowledge of modern computer assisted analytical instrumentation methods and with older techniques (i.e. titration)
Good knowledge and understanding of GMP-s and GLP-s, as well as with pertinent FDA and Health Canada guidelines
Excellent written and verbal communication skills, ability to communicate and work effectively in a team-based environment
Regular problem solving with significant degree of judgment coupled with 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) instrumentation related problems (understanding symptoms of HPLC problems and eliminating/repairing them) and first review of out-of-spec investigations.
Working conditions
- Generally, fairly pleasant surroundings. Occasional exposure to higher than normal noise levels. Frequent, daily exposure to various chemicals used in the testing of raw materials, components and finished products. Occasional exposure to unpleasant odors resulting from testing procedures. Fairly level temperatures. Mixture of standing and walking, some light lifting and/or movement of material/ instruments.
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
Sun Pharmaceuticals, Inc
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