Scientific Leader

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.

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.