Job Summary

The Technical Operations Scientific leader/ Manager will be responsible for overseeing end‑to‑end technical and operational activities related to liquid dosage pharmaceuticals, including Ophthalmic solutions, Nasal sprays, Oral liquids and Injectables. This role ensures robust manufacturing, scale‑up, technology transfer, and regulatory compliance for products intended for USFDA and Health Canada markets while leading and developing high‑performing cross‑functional 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 pilot‑scale 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 root‑cause 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 third‑party manufacturers and contract manufacturing organizations (CMOs).

People Leadership & Culture

• Lead performance discussions with employees, including monthly one‑on‑one meetings, to review progress against objectives, remove barriers, and reinforce performance expectations.
• Foster an open, honest, and two‑way communication culture to build trust and continuously strengthen leadership effectiveness through feedback and self‑development.
• 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 high‑quality talent and ensure consistent, values‑based 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 

• Bachelor’s or Master’s degree in Pharmacy, Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related discipline. 

Experience 

• Atleast 10–15 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.