Executive - Formulation Development

Ashish Life Science; Ambernath; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Ashish Life Science in India is seeking a seasoned Formulation R&D professional to drive development documentation and technology transfer activities. The role focuses on QbD, risk assessment, data review, and regulatory support across PDRs and CTD modules.

The candidate will coordinate across F&D, QA, RA and Manufacturing, ensure traceability of experimental data, and maintain high-quality development reports and technical documentation throughout lifecycle stages.

Qualifications

• Strong Formulation R&D fundamentals.
• Excellent scientific writing and technical interpretation.
• Knowledge of QbD and risk-based pharmaceutical development.
• Understanding of scale-up and technology transfer.
• Exposure to regulated-market documentation.
• Strong data-review and critical-thinking ability.
• Excellent attention to detail and document ownership.
• Proficiency in MS Word, Excel and PowerPoint.

Responsibilities

• Prepare/review PDRs and pharmaceutical development reports.
• Compile pre-formulation, formulation and process-development data.
• Document formulation optimization and development rationale.
• Prepare/review QbD, QTPP, CQA, CMA, CPP and risk-assessment documentation.
• Prepare/review MFR, BMR and Technology Transfer documents.
• Prepare scale-up, optimization and technical reports.
• Support CTD/Module 3 pharmaceutical development documentation.
• Review formulation, analytical and stability data for technical reports.
• Prepare scientific justifications and regulatory query responses.
• Ensure traceability from experimental data observations conclusions development decisions.
• Check consistency across development reports, manufacturing documents and regulatory documentation.
• Coordinate with F&D, ADL, QA, RA, Project Management and Manufacturing.
• Ensure timely completion and lifecycle management of R&D technical documentation.

Skills

Formulation R&D fundamentals

Scientific writing

QbD and risk-based development

Scale-up and tech transfer

Regulated-market documentation

Data-review & critical-thinking

Attention to detail & ownership

MS Word

Tools

MS Word

MS Excel

PowerPoint

Job description

Role & responsibilities

• Prepare/review PDRs and pharmaceutical development reports
• Compile pre-formulation, formulation and process-development data
• Document formulation optimization and development rationale
• Prepare/review QbD, QTPP, CQA, CMA, CPP and risk-assessment documentation
• Prepare/review MFR, BMR and Technology Transfer documents
• Prepare scale-up, optimization and technical reports
• Support CTD/Module 3 pharmaceutical development documentation
• Review formulation, analytical and stability data for technical reports
• Prepare scientific justifications and regulatory query responses
• Ensure traceability from experimental data observations conclusions development decisions
• Check consistency across development reports, manufacturing documents and regulatory documentation
• Coordinate with F&D, ADL, QA, RA, Project Management and Manufacturing
• Ensure timely completion and lifecycle management of R&D technical documentation

Preferred candidate profile

• Strong Formulation R&D fundamentals
• Excellent scientific writing and technical interpretation
• Knowledge of QbD and risk-based pharmaceutical development
• Understanding of scale-up and technology transfer
• Exposure to regulated-market documentation
• Strong data-review and critical-thinking ability
• Excellent attention to detail and document ownership
• Proficiency in MS Word, Excel and PowerPoint