Job Title:
Lead Research Scientist – Tech Transfer (ARPL-RDLD AR)
Date Posted: August 11, 2025
Location: Bangalore, Karnataka, India, 560099
Company: Apotex / ApoPharma
Company Overview:
ApoPharma, part of the Apotex Group of Companies, is a pharmaceutical organization dedicated to the discovery, development, and delivery of innovative medicines to improve the quality of life of patients suffering from debilitating and life-threatening diseases. A core area of research is the pathological role of iron in disease and the use of novel drugs to address iron-related conditions.
Position Summary:
The Lead Research Scientist – Tech Transfer is responsible for overseeing the scale-up, exhibit, and process validation of injectable and ophthalmic formulations developed at Apotex Research Pvt. Ltd., ensuring successful technology transfer to commercial manufacturing organizations (CMOs).
Key Responsibilities:
1. Technology Transfer & Scale-Up
Lead the tech transfer of injectable and ophthalmic formulations from R&D to manufacturing sites.
Conduct feasibility and gap analysis to ensure technology readiness at manufacturing sites.
Supervise the execution of scale-up, exhibit (EB), and validation (PV) batches.
Coordinate with CMO and Project Management teams to ensure availability of raw materials, packaging components, and process equipment.
Ensure smooth and timely transfer of technology to CMOs.
2. Process Development & Risk Assessment
Perform risk assessments to evaluate the impact of critical process parameters (CPPs) and critical material attributes (CMAs).
Design and review sampling plans for process optimization and submission batches.
Evaluate whether parameters used during development are maintained within the design space during scale-up.
3. Cross-Functional Coordination
Collaborate with various teams:
Analytical Development (AD)
Procurement & Regulatory Affairs
Quality Assurance & Packaging
Project Management
Engage with external labs to support plant-scale studies and obtain required data.
4. Documentation & Reporting
Review and compile data from scale-up, exhibit, and validation batches.
Author and review:
MFR, BMR, BPR
Stability protocols, study protocols, and reports
Raw data and laboratory notebooks
Ensure documentation compliance, archival, and data integrity as per SOPs.
5. Equipment & Compliance
Coordinate with vendors and internal service teams for equipment:
Installation, calibration, maintenance, and troubleshooting.
Prepare and maintain SOPs, ensuring compliance with internal quality systems.
Ensure adherence to cGMP, regulatory requirements, and internal guidelines.
6. Communication & Reporting
Report daily activities to senior management.
Provide technical support to the formulation development team.
Assist in development of scalable manufacturing processes.
Qualifications:
Education:
D. Pharm / M. Pharm / B. Pharm with specialization in Pharmaceutics
Experience:
Minimum 6 to 10+ years in the pharmaceutical industry with a focus on:
Injectable and ophthalmic dosage forms
Product development, tech transfer, and manufacturing
CMO collaboration and commercial readiness
Skills & Competencies:
Expertise in injectable, ophthalmic, and complex dosage form development
Strong understanding of regulatory guidelines (global & local)
Excellent verbal and written communication skills
Proficient in MS Office and relevant software tools
Ability to prioritize tasks, plan efficiently, and meet strict timelines
Good interpersonal and project management skills
Experience engaging with CMO partners and supporting regulatory submissions
Equal Opportunity & Accessibility:
ApoPharma fosters a workplace that is inclusive, accessible, and respectful of all individuals. Accommodations are available upon request during the recruitment process. If you are contacted for an interview or assessment and require accommodation, please inform the hiring team accordingly.
About Apotex:
Apotex is a global pharmaceutical company focused on the production of high-quality, affordable medications for patients around the world. Through entities like ApoPharma, the company drives innovation in drug discovery and development.
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