Apotex Inc looking for Lead Research Scientist

Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations. Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc.

Post : Lead Research Scientist, Analytical R&D

Job Description
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.

Candidate Profile
• 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.

Additional Information
Experience : 7-10 years
Qualification : M.Pharm, B.Pharm, M.Sc
Location : Bangalore, KA
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Analytical R&D
End Date : 30th May, 2024