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Lead Research Scientist - Technology Transfer

Apotex
Apotex
6-10+ years
preferred by company
10 Jan. 29, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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 – Technology Transfer
Date Posted: January 3, 2026
Location: Bengaluru, Karnataka, India – 560099
Company: Apotex Inc.
Experience Required: 6–10+ Years


About Apotex Inc.

Apotex Inc. is a Canadian-based global pharmaceutical company committed to improving access to affordable, high-quality medicines worldwide. With a diversified portfolio spanning generic, biosimilar, innovative branded pharmaceuticals, and consumer health products, Apotex serves millions of patients across global markets. Headquartered in Toronto, Canada, Apotex operates internationally, including strong regional presence in India, the United States, and Mexico, and is recognized as the largest Canadian-owned pharmaceutical company.

For more information, visit: www.apotex.com


Job Summary

Apotex is seeking an experienced Lead Research Scientist – Technology Transfer to support the seamless scale-up, exhibit, validation, and commercial manufacturing of pharmaceutical products. This role is critical in ensuring successful technology transfer of injectable and ophthalmic formulations from R&D to manufacturing sites and Contract Manufacturing Organizations (CMOs), while maintaining compliance with regulatory and quality standards.


Key Responsibilities

  • Lead technology transfer of injectable, ophthalmic, and complex dosage forms from R&D to commercial manufacturing.

  • Supervise scale-up, exhibit, process validation, and commercial batches to ensure successful execution.

  • Perform product and technology feasibility assessments, including manufacturing site readiness and gap analysis.

  • Execute risk assessments to evaluate critical process parameters (CPPs) and critical material attributes (CMAs).

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

  • Ensure development parameters remain within the defined design space during scale-up and exhibit batches.

  • Coordinate cross-functionally with QA, AD, Procurement, Packaging, Regulatory Affairs, Project Management, and Manufacturing teams.

  • Liaise with CMOs, project managers, and vendors to ensure timely availability of raw materials, packaging components, filters, and consumables.

  • Compile batch observations and prepare detailed reports for scale-up, exhibit, commercial, and process validation batches.

  • Review and approve MFRs, BMRs, BPRs, stability protocols, study protocols, executed batch records, and reports.

  • Support formulation development activities and assist in developing scalable manufacturing processes.

  • Oversee documentation lifecycle including issuance, review, completeness checks, and archival of laboratory notebooks.

  • Coordinate with external laboratories for analytical and stability studies related to plant-scale batches.

  • Support equipment installation, calibration, maintenance, and troubleshooting with vendors and service engineers.

  • Prepare, review, and ensure compliance with SOPs and regulatory guidelines.

  • Provide regular updates to reporting managers on daily operational and project activities.

  • Undertake additional responsibilities as assigned by management.


Education Qualification

  • M.Pharm / PhD in Pharmaceutics

  • B.Pharm may be considered with relevant experience


Required Skills and Competencies

  • Strong expertise in development and technology transfer of injectable and ophthalmic dosage forms.

  • Hands-on experience with scale-up, validation, and CMO technology transfer.

  • In-depth knowledge of global regulatory guidelines and compliance requirements.

  • Excellent verbal and written communication skills with strong interpersonal abilities.

  • Proven ability to engage with CMOs and support regulatory submission strategies.

  • Proficient in MS Office and relevant pharmaceutical software tools.

  • Strong planning, prioritization, and project execution skills to meet timelines.


Experience Requirements

  • Minimum 6 to 10+ years of relevant experience in injectable and ophthalmic dosage forms.

  • Demonstrated experience across formulation development, manufacturing, and technology transfer, including CMO management.


Diversity, Equity & Inclusion

Apotex is committed to creating an inclusive, accessible, and supportive work environment where all employees are valued and empowered to succeed. Reasonable accommodations are available throughout the recruitment process for applicants with disabilities.