Description

Position: Assistant Manager, Research & Development (Pharmaceuticals)

Department: Research & Development

Experience: 7 to 12 years

Education: M.Pharm / B.Pharm in Pharmaceutics, Pharmaceutical Technology, or a related field

Location: Jagatpur near Gota, Ahmedabad

Job Summary

We are looking for an experienced Assistant Manager, Research & Development to lead formulation development, trial batches, stability studies, technology transfer, and regulatory documentation for pharmaceutical products. The ideal candidate should have strong expertise in pharmaceutical R&D;, regulatory compliance, and cross-functional coordination.

Key Responsibilities

- Lead the development of new pharmaceutical products by designing formulations, planning and executing trial batches, and ensuring compliance with applicable regulatory requirements.
- Conduct research on existing products to improve their quality, stability, and efficacy.
- Plan and review pre-formulation studies, drug-excipient compatibility studies, and stability testing.
- Design, execute, and review stability studies in accordance with ICH guidelines.
- Lead technology transfer activities from R&D; to production, ensuring scalability, reproducibility, and successful commercialisation.
- Prepare, review, and maintain technical documentation, including formulation development reports, trial batch records, stability reports, SOPs, and investigation reports.
- Ensure compliance with regulatory guidelines such as FDA, ICH, WHO, and GMP.




- Support and review the preparation of regulatory dossiers, including CTD/ACTD documentation, for product registration.
- Coordinate with cross-functional teams, including Production, Quality Assurance, Quality Control, Regulatory Affairs, and Packaging Development, to ensure successful product launches.
- Ensure compliance with USFDA and oral solid dosage (OSD) standards.
- Analyze development data, identify deviations, and recommend corrective and preventive actions.
- Guide, mentor, and manage junior R&D; team members.
- Manage project timelines, priorities, and deliverables across multiple product development projects.

Required Skills & Competencies

- Strong expertise in pharmaceutical formulation development, especially oral solid dosage forms.
- Hands-on experience in trial batch execution, stability studies, and technology transfer.
- In-depth knowledge of ICH, GMP, WHO, FDA, and USFDA regulatory guidelines.
- Experience in preparing and reviewing technical and regulatory documentation, including CTD/ACTD dossiers.
- Solid analytical, problem-solving, and decision-making skills.
- Excellent communication, leadership, and cross-functional coordination skills.
- Ability to manage multiple projects and meet deadlines.

Qualifications

- M.Pharm / B.Pharm in Pharmaceutics, Pharmaceutical Technology, or a related field.
- 712 years of relevant experience in pharmaceutical Research & Development.

📌 Research And Development Manager (Ahmedabad)
🏢 BKM Health
📍 Ahmedabad