Formulation Development-Solid Oral & Liquid Oral Dosage Forms Job Vacancy in IDRS Labs Private Limited - Bengaluru, Karnataka

KEY RESPONSIBILITIES: • Lead formulation development projects from initial concept through optimization and scale-up. • Provide hands-on technical expertise in developing Oral Solid Dosage (tablets/capsules) and Liquid Oral formulations. • Prepare and review critical technical documentation, including PDR, MFR, MPR, BMR, BPR, and Study Protocols. • Plan and execute pre-formulation studies, prototype trials, optimization studies, and troubleshooting activities. • Compile and interpret analytical data to define strategic next steps and design forward-looking development paths. • Develop robust formulations using Quality by Design (QbD) principles to meet product requirements and regulatory expectations. • Support product development for NDA, ANDA, and hybrid/505(b)(2) filings targeting both regulated and emerging markets. • Evaluate formulation and process parameters to identify opportunities for quality improvement and value addition. • Collaborate closely with cross-functional teams, including Analytical, Quality, Regulatory, Manufacturing, and Technology Transfer. • Support scale-up operations, exhibit/registration batch manufacturing, and technology transfer activities. • Investigate formulation and process-related issues to deliver effective, science-based technical solutions. • Review development data and provide actionable recommendations for product and process improvements. • Lead, guide, and mentor junior formulation development team members to foster technical growth. • Ensure all formulation development activities are completed within defined timelines and quality standards. Required Qualifications • M. Pharm / Ph. D in Pharmaceutics or Pharmaceutical technology qualification. • 7–12 years of relevant experience in Formulation Development and technology transfer of solid oral, liquid oral formulations. Preferred Candidate Profile • Strong technical documentation and project management skills. • Strong hands-on experience in Oral Solid Dosage (OSD) • Experience in Liquid Oral formulations • Knowledge on QbD based product development for global regulatory filing. • Experience in NDA & ANDA regulatory filings for regulated and emerging markets, including hybrid or 505(b)(2) applications. • Hands-on experience in technical Documentations like PDR, MFR, MPR, BMR, BPR, Study Protocols, etc. • Expertise in pre-formulation studies, Oncology molecules handling is an added advantage • Good understanding of pharmaceutical development principles and regulatory requirements. • Strong exposure to formulation optimization, troubleshooting & scale-up • Prior experience leading or mentoring a formulation development team.