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Lead Rsrch Scientist, Tchtr-Arpl-Rdld Ar

6-10 years
Not Disclosed
10 Sept. 23, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Lead Research Scientist – Tech Transfer (ARPL-RDLD AR)
Company: ApoPharma (Member of Apotex Group)
Location: Bangalore, KA, India, 560099
Date Posted: September 9, 2025


About ApoPharma

ApoPharma is a pharmaceutical company focused on the discovery, development, and delivery of innovative medicines aimed at improving the quality of life for patients with debilitating and life-threatening conditions. A major research focus is on the pathological role of iron in human disease and the development of novel therapeutics to address conditions influenced by iron.


Job Summary

The Lead Research Scientist – Tech Transfer will supervise scale-up, exhibit, and process validation batches, ensuring the efficient technology transfer of products developed at Apotex Research Pvt. Ltd. This role involves close coordination with cross-functional teams and Contract Manufacturing Organizations (CMOs) to ensure successful commercialization.


Key Responsibilities

  • Tech Transfer & Scale-Up

    • Lead technology transfer of injectable and ophthalmic formulations from R&D to commercial scale.

    • Evaluate product and technology feasibility at manufacturing sites; perform gap analysis to ensure site readiness.

    • Ensure smooth execution of scale-up, exhibit, and commercial batches.

  • Documentation & Compliance

    • Prepare and maintain documentation for onsite execution of batches.

    • Review and compile MFR, BMR, BPR, stability protocols, and reports.

    • Maintain laboratory notebooks and ensure proper archival of raw data.

    • Prepare and implement SOPs in compliance with regulatory guidelines.

  • Process & Risk Management

    • Conduct risk assessments to evaluate the impact of critical process parameters and material attributes.

    • Design and review sampling plans for scale-up, optimization, and submission batches.

    • Verify that parameters established during development are within the defined design space during scale-up.

  • Coordination & Support

    • Liaise with internal departments (AD, QA, Procurement, Regulatory Affairs, Packing, Project Management) for smooth batch execution.

    • Coordinate with CMOs to ensure timely availability of raw and packaging materials, filters, tubing, etc.

    • Support formulation development teams with technical guidance and scalable process design.

    • Engage with external labs to ensure successful completion and receipt of study data.

    • Coordinate with vendors and service engineers for installation, calibration, maintenance, and troubleshooting.

  • Reporting & Other Duties

    • Report daily activities to the next-level manager.

    • Undertake additional tasks as assigned by management.


Qualifications

  • Education: D. Pharma / M. Pharma in Pharmaceutics or B. Pharma.

  • Experience: Minimum 6–10+ years in injectable, ophthalmic, and complex drug product development, manufacturing, and technology transfer (CMO experience preferred).

  • Skills & Competencies:

    • Strong command over verbal and written communication; excellent interpersonal skills.

    • Proficiency in MS Office and advanced software tools.

    • Sound knowledge of regulatory guidelines.

    • Strong planning, prioritization, and task management skills.

    • Ability to engage with CMOs and support submission plans.


Work Environment

ApoPharma is committed to fostering an inclusive and accessible work environment. Accommodation is available for applicants with disabilities during the recruitment process.


Keywords / Related Roles

  • Research & Development

  • Injectable & Ophthalmic Formulations

  • Technology Transfer

  • Process Validation

  • Pharmaceutical Scale-Up