Research And Development Manager

BKM Health Pvt. Ltd.; Ahmedabad District; Sur place; INR 2 000 000 - 3 500 000; Plein temps

Résumé du poste

BKM Health Pvt. Ltd. in India seeks an experienced Assistant Manager, Research & Development to lead formulation development, trial batches, stability studies, and technology transfer for pharmaceutical products.

The candidate should possess deep knowledge of regulatory requirements (FDA, ICH, WHO, GMP) and strong cross-functional coordination to ensure successful product registrations and timely deliveries.

Qualifications

• Experience in oral solid dosage form development.
• Trial batches and stability studies experience.
• Familiarity with ICH, GMP, WHO, FDA guidelines.
• Experience in CTD/ACTD dossiers.
• Strong analytical and decision-making skills.
• Excellent communication and leadership.
• Ability to manage multiple projects.

Responsabilités

• Lead development of new pharmaceutical products by designing formulations, planning and executing trial batches, and ensuring regulatory compliance.
• Conduct research to improve product quality, stability, and efficacy.
• Plan and review pre-formulation, drug-excipient compatibility, and stability testing.
• Design and review stability studies per ICH guidelines.
• Lead technology transfer from R&D to production for scalability.
• Prepare and maintain technical documentation including reports and SOPs.
• Ensure compliance with FDA, ICH, WHO, and GMP guidelines.
• Support regulatory dossiers and CTD/ACTD documentation.
• Coordinate with Production, QA, QC, Regulatory Affairs, and Packaging Development for launches.
• Ensure USFDA and OSD standards compliance.
• Analyze development data, identify deviations, and recommend CAPAs.
• Mentor and manage junior R&D team members.
• Manage project timelines and deliverables across multiple projects.

Connaissances

Formulation development

Trial batches

Stability studies

Technology transfer

Regulatory documentation

Regulatory compliance

Cross-functional

Leadership

Project management

Analytical

Formation

M.Pharm / B.Pharm in Pharmaceutics, Pharmaceutical Technology

Description du poste

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.
• Strong 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.