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Job Description

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

- Solid 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.

Location

Bommasandra Industrial Area, Bengaluru, Karnataka, India 560099

Qualification

M.Pharm

Department

General, Formulation Research And Development, Formulation R&D;, Formulation Development

Skills

Formulation Development, Oral Solid Dosage, Liquid Oral Dosage, PDR, NDA, ANDA ,Formulation Optimization, QbD, Scale-up , Troubleshooting , Team Leadership

Specialization

Oral Solid Dosage Forms

Oral Liquid Dosage Forms

QbD based product development for global regulatory filing

NDA & ANDA regulatory filings for regulated and emerging markets, including hybrid or 505(b)(2) applications

- Expertise in pre-formulation studies

Oncology molecules handling

📌 Formulation Development-Solid Oral & Liquid Oral Dosage Forms (Bengaluru)
🏢 Nextenti Tech Private
📍 Bengaluru