Senior Executive, R&D- Formulation & Development
pell· R&D-Formulation & Development
About this role
Job Summary:
We are looking for a highly competent and experienced Senior Formulation & Development (F&D) Chemist with extensive hands-on exposure in the development of solid oral dosage forms, specifically tablets and pellets. The candidate must possess in-depth knowledge of formulation strategies, process optimization, and regulatory documentation, with a strong command over the preparation of Product Development Reports (PDRs) in line with global regulatory expectations.
Key Responsibilities:
PDR Preparation & Documentation:
- Independently prepare comprehensive and compliant Product Development Reports (PDRs), including:
- Justification for formulation approach and component selection
- Process design, optimization, and scalability strategy
- Risk assessment (FMEA) and control strategy
- Compatibility, stability, and in-process data interpretation
- Troubleshooting and change justifications (if applicable)
- Prepare supporting documentation such as MFR, FPSs.
- Ensure all documentation complies with ICH, USFDA, EU, and other applicable regulatory guidelines.
Formulation Development (Tablets & Pellets Focus):
- Develop robust and scalable formulations for immediate-release (IR), modified-release (MR), and delayed-release (DR) tablets as well as multi-particulate pellet formulations (coated or uncoated).
- Conduct pre-formulation studies, API characterization, excipient screening, and compatibility studies.
- Design and execute lab-scale, exhibit, and validation batches of tablets and pellets using QbD principles.
- Optimize critical formulation and process parameters for wet granulation, dry granulation, direct compression, extrusion–spheronization, layering, and pellet coating processes.
- Conduct process optimization and scale-up in coordination with manufacturing or pilot plant teams.
Regulatory & Quality Compliance:
- Ensure all development and documentation activities are conducted in accordance with cGMP, GLP, and global regulatory expectations.
- Collaborate with QA and Regulatory Affairs during internal and external audits, as well as during regulatory filings.
- Contribute to dossier preparation by providing required CMC data and responding to technical queries.
Cross-Functional Collaboration:
- Work closely with Analytical R&D, Packaging, QA, Regulatory, and Manufacturing departments to ensure project alignment and successful execution.
- Support technology transfer to commercial production teams with detailed technical input and documentation.
Team Leadership & Mentoring:
- Guide junior scientists and trainees in conducting formulation trials, data analysis, and documentation practices.
- Train team members on best practices for tablets and pellets formulation and PDR preparation.
Qualifications & Experience:
- Education: M.Pharm (Pharmaceutics) or B.Pharm
- Experience: 5–8 years in pharmaceutical F&D, with specific hands-on experience in tablets and pellets formulation
- Must-Have Skills:
- Deep understanding of PDR preparation, granulation techniques, compression, coating, and pelletization processes
- Strong expertise in scientific writing and PDR preparation
- Experience in formulation development for regulated markets (e.g. EU, ROW, Russia, Chille and other regulated Market)
- Preferred: Exposure to QbD and regulatory filing
Frequently Asked Questions
Is the salary disclosed for the Senior Executive, R&D- Formulation & Development position at pell?
The salary for this Senior Executive, R&D- Formulation & Development role at pell is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Senior Executive, R&D- Formulation & Development position at pell located?
This Senior Executive, R&D- Formulation & Development role at pell is based in Palghar, MH, India. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Senior Executive, R&D- Formulation & Development role at pell full-time or part-time?
This is listed as a FULL TIME position. It is posted as a Senior Executive, R&D- Formulation & Development role in the R&D-Formulation & Development department at pell.
Which team or department does the Senior Executive, R&D- Formulation & Development at pell belong to?
This Senior Executive, R&D- Formulation & Development position is part of the R&D-Formulation & Development department at pell. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Senior Executive, R&D- Formulation & Development position at pell?
Click the "Apply Now" button on this page. You will be redirected to pell's official application portal hosted on keka where you can submit your application directly.
When was the Senior Executive, R&D- Formulation & Development job at pell posted?
This Senior Executive, R&D- Formulation & Development position at pell was posted on Jun 24, 2026. Apply as soon as possible — early applications are often reviewed first.
Senior Executive, R&D- Formulation & Development
pell
You'll be redirected to pell's official application page on keka.