Lead Research Scientist, AD-ARPL-AR&D AR

ApoPharma, a member of the Apotex group of companies, is a pharmaceutical company devoted to the discovery, development and provision of new medicines to help improve the quality of life of patients with debilitating and life-threatening diseases. Investigation into the pathological role of iron in human disease, and how to use novel medicines to treat conditions created or worsened by iron, is a major research focus of ApoPharma.

Job Summary

• Responsible for developing, validating and applying analytical methods in compliance with current compendial pharmacopoeias, ICH, SOP and GMP requirements.
• Testing and evaluation of R&D samples in support of selection of API suppliers, specification development and NPD process.
• Providing scientific support to Product Evaluation, Formulation and Process Development.
• Perform most complex tasks and high priority special projects.
• This position requires effective problem solving and resolution in designated day-to-day operations.
• This role requires to collaborate & participate meetings with multidisciplinary teams to resolve complex product development issues.
• Lead projects as assigned, working both independently and in collaboration with the team to deliver assignments on time.
• Review of laboratory data, instrument logbook and reports wherever applicable.

Job Responsibilities

• Prepares working plan for assigned projects and provides timeline to Manager.
• Develops stability indicative analytical methods for drug substance and finished product.
• Identify and resolves analytical method problems as required.
• Responsible for all activities in Analytical Development, including cGLP, documentation and implementation of departmental quality systems.
• Applies AQbD approach to analytical method development where applicable.
• Responsible for protocol preparation and approval, planning, execution, review and report preparation of various analytical method validation parameters.
• Ensures analytical methods validation is conducted according to approved validation protocols in a timely manner with accuracy and precision in compliance of laboratory SOP and guidelines.
• Responsible for method verifications and publishing of analytical methods.
• Maintenance and archival of analytical method validation documents.
• Performs all analytical tests for drug substance, including assay, related compounds, identifications and wet chemistry for API evaluation.
• Performs all analytical tests for PE/PO samples, including assay, degradation products and dissolution.
• Performs all analytical tests for API releasing, including assay, degradation products, dissolution and physical testing.
• Conducts other tests required for dosage submissions.
• Conducts lab investigations for OOS and OOT results.
• Responsible for initiation, execution and completion of technology transfer and collaborative validation activities of analytical methods to and / or from other departments of Apotex wherever applicable.
• Responsible for technology transfer and Transfer of analytical procedures activity to support the supervisor.
• Communicating the requirements for the Leaders and within the team members for effective cGLP procedures and departmental quality systems to achieve all outcomes.
• With minimal guidance, performs troubleshooting on complex issues with respect to the stability of drug substances and drug products.
• To participate in the mandatory trainings to execute the day to day job responsibilities.
• Assist in departmental housekeeping and other pertinent duties as assigned in accordance with safety and GLP.
• Develops and maintain strong relationships within Analytical R&D to ensure that the projects are delivered on time.
• Practice and up-gradation of knowledge with respect to cGMP.
• Performs all work in accordance with all established regulatory and compliance and safety requirements.
• Work as a member of a team to achieve all outcomes.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education

• A graduate/post graduate in analytical chemistry, organic chemistry, pharmaceutical sciences, or related field.

• Knowledge, Skills and Abilities

• knowledge of the instrumentation such as HPLC, GC, UV, IR spectrophotometer and dissolution apparatus, wet chemistry and analytical bench techniques.

• Knowledge in HPLC method development and method validation.
• Knowledge on preparation and review of various documents like SOP's, Formats, Protocols, Reports, analytical data, investigation and deviation reports.
• Should have well versed knowledge on regulatory guidelines and thorough knowledge on cGMP activities
• Should possess troubleshooting knowledge on Instruments and analysis.
• Knowledge of wet chemistry, analytical bench techniques, Window-based software, and automated data acquisition systems.
• Working knowledge of LIMS is an asset.

• Good written and verbal English communication skills.

• Experience

• Minimum of 7-10 years of experience in method development and validation in pharmaceutical industry.?

• Extensive knowledge and experience in analytical chemistry.?

At ApoPharma, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. ApoPharma offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.