Lead Research Scientist – Technology Transfer
Company: Apotex Inc.
Location: Bangalore, Karnataka, India (560099)
Posting Date: February 1, 2026
Employment Type: Full-Time
About Apotex Inc.
Apotex Inc. is a Canadian-based global pharmaceutical organization dedicated to improving access to affordable, high-quality medicines and health products worldwide. With a diversified portfolio that includes generic, biosimilar, innovative branded pharmaceuticals, and consumer health products, Apotex operates across multiple international markets. Headquartered in Toronto, the company maintains strong regional operations in North America, Latin America, and India, supporting global development, manufacturing, and regulatory excellence.
Position Summary
The Lead Research Scientist – Technology Transfer is responsible for supervising scale-up, exhibit, and process validation batches to ensure the successful and compliant transfer of pharmaceutical technologies from research and development to commercial manufacturing. This role focuses on injectable and ophthalmic dosage forms and involves close coordination with internal cross-functional teams, contract manufacturing organizations (CMOs), and external partners to ensure site readiness and seamless product commercialization.
Key Responsibilities
Technology Transfer and Scale-Up
Lead end-to-end technology transfer of injectable and ophthalmic formulations from R&D to commercial manufacturing sites
Supervise scale-up, exhibit, and process validation (PV) batches to ensure successful execution and regulatory compliance
Conduct gap analysis to assess product feasibility, process capability, and site readiness at manufacturing locations
Process Development and Risk Management
Perform risk assessments to evaluate the impact of critical process parameters (CPPs) and critical material attributes (CMAs)
Design and review sampling plans for scale-up, process optimization, exhibit, and submission batches
Verify that development-stage parameters remain within the defined design space during scale-up and exhibit batches
Documentation and Regulatory Compliance
Oversee on-site documentation and timely execution of scale-up, exhibit, and validation batches
Compile batch observations and prepare detailed technical reports for scale-up, exhibit, commercial, and PV batches
Review and approve MFRs, BMRs, BPRs, executed batch records, stability protocols, study protocols, and technical reports
Ensure issuance, review, completeness checks, and archival of laboratory notebooks and raw data
Cross-Functional and External Coordination
Coordinate with formulation development, analytical development, QA, procurement, packaging, regulatory affairs, project management, and manufacturing teams
Collaborate with CMOs and project managers to ensure availability of raw materials, packaging components, filters, tubing, and consumables prior to batch execution
Support technology transfer to external CMOs and provide technical troubleshooting during manufacturing operations
Liaise with external laboratories to ensure timely completion and receipt of plant-scale study data
Operational Excellence and Leadership
Provide technical support to formulation development teams and contribute to scalable manufacturing process design
Support installation, calibration, maintenance, and troubleshooting of manufacturing equipment in coordination with vendors and service engineers
Prepare, review, and ensure compliance with SOPs, cGMP guidelines, and internal quality systems
Report daily operational activities and project updates to the reporting manager
Undertake additional responsibilities as assigned to support business and project objectives
Required Qualifications and Experience
Education:
PhD or M.Pharm in Pharmaceutics, or
Bachelor’s degree in Pharmacy (B.Pharm) with relevant industry experience
Experience:
Minimum 6 to 10+ years of hands-on experience in development, manufacturing, and technology transfer of injectable and ophthalmic dosage forms
Proven expertise in technology transfer activities involving CMOs and commercial manufacturing sites
Key Skills and Competencies:
Strong technical knowledge of injectable, ophthalmic, and complex drug product development
In-depth understanding of regulatory guidelines and global cGMP requirements
Proven experience in scale-up, process validation, and commercial batch execution
Excellent verbal and written communication skills with strong interpersonal abilities
Ability to prioritize tasks, manage timelines, and plan work activities effectively
Proficiency in MS Office and advanced pharmaceutical software tools
Experience supporting regulatory submissions through robust technical documentation
Why Join Apotex
Apotex provides a collaborative and innovation-driven environment where scientific leaders play a critical role in advancing global healthcare access. Employees benefit from exposure to complex products, global manufacturing networks, and continuous professional development opportunities.
Equal Opportunity and Accessibility
Apotex Inc. is committed to fostering an inclusive, accessible, and respectful workplace. Reasonable accommodations are available throughout the recruitment process for applicants with disabilities, ensuring equal opportunity for all candidates.
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