Officer to Executive – Research & Development (API R&D)
Location: Dahej SIR / SEZ, Bharuch, Gujarat, India
Employment Type: Full-Time
Function: Research & Development – API Process Development
Job ID: 4745
Job Overview
We are seeking qualified and motivated R&D professionals (Officer to Executive level) to support API Research & Development and Process Development activities at our Dahej SIR facility in Gujarat. The role involves hands-on participation in process verification, plant validation, technology transfer, and cross-functional collaboration to ensure robust, scalable, and compliant API manufacturing processes.
This position is ideal for candidates with strong experience in API R&D, scale-up, validation, and regulatory documentation, who are eager to contribute to plant-ready processes in a regulated pharmaceutical environment.
Key Responsibilities
R&D Process Development & Validation
Participate in project planning and allocation of R&D activities across process development programs.
Monitor process verification schedules, plant verification batches, and prepare detailed technical reports.
Evaluate yield, impurity, and quality trends for R&D verification and plant validation batches.
Prepare, review, and interpret characterization data for working standards, key starting materials (KSMs), intermediates, and related substances.
Support plant-scale investigations and troubleshooting in collaboration with Production and Quality Assurance teams.
Documentation & Regulatory Support
Prepare, review, and approve documentation related to process development, verification, and validation batches.
Assist in preparation of regulatory documents including Consent for Establishment (CFE), Drug Licenses, and development reports.
Review stability study data generated for development and validation batches.
Support generation of protocols, reports, and technical summaries for regulatory submissions.
Analytical & Cross-Functional Coordination
Ensure timely submission of R&D and validation samples to Analytical Development Laboratories (ADL) and track analytical results.
Coordinate sample dispatch of raw materials, intermediates, and APIs to API R&D teams for specialized testing.
Maintain effective communication with internal R&D centers and cross-functional stakeholders for technical discussions and project updates.
Compliance, Quality & Continuous Improvement
Ensure compliance with cGMP, GLP, and data integrity requirements across all R&D activities.
Participate in technology transfer from R&D to manufacturing and support smooth scale-up to commercial production.
Assist in deviation investigations, root cause analysis, and CAPA implementation.
Maintain accurate records, logbooks, and sample traceability in accordance with QA requirements.
Participate in internal and external audits related to R&D and process development.
Equipment & Team Development
Perform routine verification and review calibration of laboratory instruments used in process development.
Ensure proper maintenance of R&D equipment and initiate calibration or servicing requests as per schedules.
Train and mentor junior team members on laboratory safety, process understanding, and documentation practices.
Contribute to continuous improvement initiatives and cost optimization in API process development.
Education & Qualifications
Preferred Qualifications:
Master’s Degree (M.Sc.) in Organic Chemistry.
Ph.D. in Chemistry or Pharmaceutical Sciences (highly desirable).
Experience Requirements
3 to 7 years of hands-on experience in API R&D and process development within a pharmaceutical manufacturing environment.
Proven exposure to process scale-up, plant validation, and technology transfer activities.
Required Skills & Competencies
API Process Development and Scale-Up – Advanced
Plant Validation and Technology Transfer – Intermediate to Advanced
Analytical Data Interpretation – Intermediate
Process Troubleshooting and Investigations – Intermediate
Documentation Review (Process Development, Validation, Stability) – Advanced
Knowledge of Regulatory Documentation (CFE, Drug Licenses) – Intermediate
cGMP, GLP, and Data Integrity Compliance – Advanced
Instrument Calibration and Equipment Review – Intermediate
Cross-Functional Communication and Collaboration – Intermediate to Advanced
Training, Coaching, and Mentorship – Intermediate
Why Join Us?
This role offers an opportunity to work in a state-of-the-art API R&D environment with direct exposure to process development, plant validation, and regulatory-driven projects. You will collaborate closely with experienced R&D, QA, QC, and manufacturing teams while contributing to scalable and compliant pharmaceutical processes.
Apply Now
Interested candidates are encouraged to apply through thepharmadaily.com and take the next step in building a strong career in API Research & Development and Process Innovation.
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