Scientific Leader

About Apotex Inc.

Apotex is a Canadian-based global health company. We improve everyday access to affordable innovative medicines and health products for millions of people worldwide with a broad portfolio of generic biosimilar innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto with regional offices globally including in the United States Mexico and India we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions.

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Job Summary

The Technical Operations Scientific leader/ Manager will be responsible for overseeing endtoend technical and operational activities related to liquid dosage pharmaceuticals including Ophthalmic solutions Nasal sprays Oral liquids and Injectables. This role ensures robust manufacturing scaleup technology transfer and regulatory compliance for products intended for USFDA and Health Canada markets while leading and developing highperforming crossfunctional teams.

Job Responsibilities

Technical Operations & Manufacturing

• Lead technical operations for liquid dosage forms including ophthalmic solutions and suspensions oral liquids nasal sprays and sterile injectables (parenterals).
• Serve as the primary technical interface during technology transfer from R&D to pilotscale and commercial manufacturing sites.
• Troubleshoot complex manufacturing challenges related to formulation filling sterilization and packaging.
• Evaluate and provide technical input to the Formulation group to ensure acceptability and scalability of lead formulations.
• Oversee the manufacture of stability and clinical lots in full compliance with Apotex quality systems regulatory requirements and safety standards.
• Partner with Validation to define cleaning process and sterilization validation requirements for new products and processes.
• Manage the preparation of development protocols technical reports technology transfer documents (TTTs) master documents and project updates.
• Support and guide TO NPL team members to achieve defined project outcomes as required.
• Act as a delegate for the Associate Director making independent decisions to ensure continuity of routine departmental operations when required.
• Lead investigations into complex process issues applying innovative and unconventional approaches to rootcause analysis and corrective action planning.
• Oversee preparation of combination product documentation including Design History Files (DHF) Risk Management Files and Design & Development Plans.
• Manage development and execution of Technology Transfer Packages for transfer to thirdparty manufacturers and contract manufacturing organizations (CMOs).

People Leadership & Culture

• Lead performance discussions with employees including monthly oneonone meetings to review progress against objectives remove barriers and reinforce performance expectations.
• Foster an open honest and twoway communication culture to build trust and continuously strengthen leadership effectiveness through feedback and selfdevelopment.
• Create a culture that values trust employee growth and development while demonstrating core values of Collaboration Courage Perseverance and Passion.
• Leverage professional networks to attract and hire highquality talent and ensure consistent valuesbased onboarding experiences.
• Ensure direct reports comply with all company policies quality systems safety requirements and compliance programs.
• Collaborate with Quality Regulatory Affairs R&D Supply Chain and external CMOs/CDMOs.

Quality Systems & Documentation

• Support technical writers in the preparation review approval and publication of manufacturing master documents and SOPs within QMS and SAP.
• Ensure technical writers receive all required updated drafts and supporting documentation to facilitate timely QMS assessments and approvals.

Regulatory & Compliance

• Ensure compliance with cGMP GLP and applicable regulatory standards.
• Provide technical support for US FDA and Health Canada inspections and regulatory interactions.
• Prepare review and approve CMC sections for NDAs ANDAs supplements and lifecycle management submissions.
• Review and approve validation protocols reports change controls deviations CAPAs and risk assessments.

Job Requirements

Education

• Bachelors orMasters degree in Pharmacy Chemistry Chemical Engineering Pharmaceutical Sciences ora relateddiscipline.

Experience

• Atleast 1015 years of progressive experience in the pharmaceutical industry.
• Hands-on experience with liquid dosage drug development and commercial manufacturing including injectables ophthalmics and nasal sprays.
• Strong background in technology transfer scale-up and post-approval manufacturing support.
• Proven people management and leadership experience.
• Strong understanding of cGMP GLP SOPs SWPs SUPAC FDA and Health Canada requirements.
• Excellent problem-solving analytical and decision-making abilities.

At Apotex we are committed to fostering a welcoming and accessible work environment where all everyone feels valued respected and supported to succeed.

We offer 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.

The hiring range for this position is $ 95594.40 - $ 133832.16 CAD per year. The final agreed-upon salary may vary based on factors such as job-related knowledge skills and experience.

We are looking for top talent. If your qualifications differ from those listed above the scope of work and final agreed-upon salary may be adjusted to reflect your individual qualifications.

The Apotex Total Rewards package goes beyond base salary. Apotex offers bonus programs based on your position in the organization you can excel based on our pay-for-performance philosophy. With comprehensive benefits a pension plan to help you save for retirement and learning and development opportunities we provide a comprehensive package for your personal and professional development.

Apotex will use artificial intelligence to screen select and/or assess your application for this job.

This job posting is for a role that is currently available and vacant at Apotex.

Employment Type : Full Time
Experience: years
Vacancy: 1