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Executive - Analytical Research & Development (Nos)

Apotex
Apotex
3-6 years
preferred by company
10 Feb. 9, 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

Executive – Analytical Research & Development (Non-Oral Solids)

Company: Apotex Inc.
Location: Bangalore, Karnataka, India (560099)
Posting Date: February 2, 2026
Employment Type: Full-Time


About Apotex Inc.

Apotex Inc. is a Canadian-based global pharmaceutical organization committed to improving access to affordable, high-quality medicines and healthcare products worldwide. With a diverse portfolio encompassing generic, biosimilar, innovative branded pharmaceuticals, and consumer health products, Apotex operates across multiple international markets. Headquartered in Toronto, Canada, the company maintains strong regional operations in the United States, Mexico, and India, supporting global research, development, manufacturing, and regulatory excellence.


Position Summary

The Executive – Analytical Research & Development (Non-Oral Solids) is responsible for the execution of analytical method development, optimization, validation, and verification activities in compliance with global regulatory and quality standards. This role supports compendial and in-house analytical methods, site transfer activities, regulatory submissions, Method Life Cycle Management (MLCM), supplier-driven changes (SDC), and other procedural updates, ensuring robust analytical support for pharmaceutical development and commercialization.


Key Responsibilities

Analytical Method Development and Validation

  • Execute analytical method optimization and development for non-oral solid dosage forms

  • Perform method validation and verification for compendial, in-house, cleaning, MLCM, and supplier-driven change methods in accordance with regulatory requirements

  • Prepare and review method validation, verification, and method transfer protocols and reports

Method Transfer and Regulatory Support

  • Execute analytical method transfer studies and prepare comprehensive transfer reports

  • Conduct analytical studies to support regulatory queries and submission requirements

  • Support method life cycle management activities and continuous improvement initiatives

Quality and Compliance

  • Perform all analytical activities in accordance with cGMP, cGLP, regulatory compliance, and safety standards

  • Support Quality Control Laboratory operations, including documentation, data integrity, and implementation of departmental quality systems

  • Ensure compliance with Global Quality policies, Business Ethics and Compliance programs, Safety and Environment policies, and HR guidelines

Collaboration and Operational Excellence

  • Collaborate effectively with cross-functional teams to achieve project timelines and quality objectives

  • Demonstrate organizational values including collaboration, courage, perseverance, and passion

  • Perform additional responsibilities as assigned to support departmental and organizational goals


Required Qualifications and Experience

Education:

  • MSc in Chemistry, Pharmaceutical Sciences, or equivalent, or

  • Bachelor’s degree in Pharmacy (B.Pharm) or equivalent qualification

Experience:

  • Minimum 3 to 6 years of experience in a GMP-regulated pharmaceutical industry environment

Technical Skills and Competencies:

  • Hands-on experience in analytical method development and optimization

  • Proficiency in analytical techniques, including multi-parameter analysis using HPLC

  • Strong understanding of method validation, verification, and transfer principles

  • Proficient in Microsoft Office applications, including Word and Excel

  • Ability to manage multiple analytical activities and meet project timelines effectively

  • Strong attention to detail and commitment to data integrity and regulatory compliance


Why Join Apotex

Apotex offers a collaborative and science-driven work environment where analytical professionals contribute directly to the development and lifecycle management of high-quality pharmaceutical products. Employees gain exposure to global regulatory standards, advanced analytical methodologies, and continuous learning opportunities.


Equal Opportunity and Accessibility

Apotex Inc. is an equal opportunity employer committed to building an inclusive and accessible workplace. Reasonable accommodations are available throughout the recruitment process for candidates with disabilities to ensure equitable participation.