Assistant Manager

Bal Pharma Limited

Bommasandra

On-site

INR 1,800,000 - 2,800,000

Full time

9 days ago

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Job summary

Bal Pharma Ltd. is seeking an experienced Assistant Manager – Formulation R&D (OSD) to lead development activities for Europe, ROW, and Indian markets. Bengaluru-based role focusing on OSD tablets and capsules, with responsibilities spanning development, tech transfer, and regulatory alignment.

The candidate will oversee BE studies, review BMR/MFR/PDR, and ensure GMP-compliant processes. Leadership, cross-functional coordination, and strong analytical skills are essential for timely project

Qualifications

  • 7–10 years of hands-on experience in Formulation R&D.
  • Strong expertise in OSD formulation development (Tablets/Capsules).
  • Experience in Europe, ROW, and Indian regulated markets.
  • Practical knowledge of technology transfer, process validation, and commercial troubleshooting.
  • Good understanding of BE studies and regulatory requirements.
  • Experience in preparing and reviewing BMR, MFR, and PDR documents.
  • Strong analytical, problem-solving, communication, and leadership skills.

Responsibilities

  • Lead Oral Solid Dosage (OSD) formulation development, including tablets and capsules.
  • Develop and optimize formulations for regulated markets.
  • Handle technology transfer from R&D to manufacturing.
  • Manage process validation and troubleshoot formulation/process issues in commercial products.
  • Review BMR, MFR, PDR, analytical data, and validation reports.
  • Ensure compliance with regulatory guidelines and GMP requirements.
  • Understand and support BE studies.
  • Coordinate with Analytical R&D, Production, QA, QC, and Regulatory Affairs teams.
  • Prepare and maintain technical documentation and development reports.
  • Guide junior team members and ensure timely completion of projects.

Skills

OSD formulation development
Technology transfer
Process validation
BMR MFR PDR review
Regulatory compliance
BE studies
Leadership
Analytical skills

Education

M.Pharm / M.Sc. / Ph.D. in Pharmaceutics

Job description

ASSISTANT MANAGER FORMULATION R&D (OSD)

Company: Bal Pharma Ltd.
Location: Bengaluru
Experience: 7–10 Years
Qualification: M.Pharm / M.Sc. / Ph.D. in Pharmaceutics or relevant discipline

Job Summary

Bal Pharma Ltd. is looking for an experienced Assistant Manager – Formulation R&D (OSD) to lead formulation development activities for Europe, ROW, and Indian regulated markets.

Key Responsibilities
  • Lead Oral Solid Dosage (OSD) formulation development, including tablets and capsules.
  • Develop and optimize formulations for regulated markets.
  • Handle technology transfer from R&D to manufacturing.
  • Manage process validation and troubleshoot formulation/process issues in commercial products.
  • Review BMR, MFR, PDR, analytical data, and validation reports.
  • Ensure compliance with applicable regulatory guidelines and GMP requirements.
  • Understand and support Bioequivalence (BE) studies.
  • Coordinate with Analytical R&D, Production, QA, QC, and Regulatory Affairs teams.
  • Prepare and maintain technical documentation and development reports.
  • Guide junior team members and ensure timely completion of projects.
Required Skills & Experience
  • 7–10 years of hands-on experience in Formulation R&D.
  • Strong expertise in OSD formulation development (Tablets/Capsules).
  • Experience in Europe, ROW, and Indian regulated markets.
  • Practical knowledge of technology transfer, process validation, and commercial troubleshooting.
  • Good understanding of BE studies and regulatory requirements.
  • Experience in preparing and reviewing BMR, MFR, and PDR documents.
  • Strong analytical, problem-solving, communication, and leadership skills.
Preferred Candidate Profile

Candidates currently working in Formulation R&D / Formulation Development within the pharmaceutical industry, with hands-on experience in OSD products and regulated markets.

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