Job Description

Job Purpose:

The main responsibilities of this position are to support scientific programs including development of new analytical and remediation of existing analytical methods and scientific challenges as well as to provide technical expertise to product development chemists. Key duties include development of new analytical methods, preparation of protocols and reports and other documents for regulatory submissions. Scientist trains Chemists, Sr. Chemists and provides support to Sr. Scientists and Supervisors. Moderate number of duties includes hands on work following cGMP requirements.

Duties and Responsibilities:

• Conduct method validation for complex methods and lead method validation efforts conducted by the smaller teams of Chemists or Sr. Chemists
• Take ownership of select activities leading to product approval (ie. deficiency letter responses for chemistry issues, investigations, etc.)
• Provide Scientific SME support to R&D personnel in analytical and product development areas.
• Perform testing using advanced GC/HPLC/MS techniques as well as specialized testing using particle size analysis, in-vitro, spectroscopic analysis and other techniques as required
• Independently prepare method validation protocols, method development and method validation reports
• Evaluate spectroscopic data (NMR, IR, MS)
• Isolate/identify/synthesize impurities as required.
• 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 (CAPA\'s)
• Participate in Internal, Customer and Regulatory Audits
• 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

• B. Sc. in Chemistry or related pharmaceutical discipline. Candidates possessing M.Sc. or Ph.D. degrees in Chemistry are preferred.
• Minimum five (5) years of relevant experience in a pharmaceutical environment.
• Demonstration of leadership and ability to train other Chemists in a team based environment and team members working with on various projects.
• In-depth theoretical and practical knowledge of gas and liquid chromatography, spectroscopy and other analytical techniques employed in the pharmaceutical development
• Advanced 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)
• Excellent knowledge and understanding of GMP-s and GLP-s, as well as with pertinent FDA, Health Canada and other regulatory requirements and guidance
• 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.

• 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.

Sun Pharmaceutical Industries