Assistant Manager- R&D Formulations & Development
pell· R&D-Formulation & Development
About this role
Role Summary
To lead F&D formulation development for OSD products (tablets and pellets) — driving pre-formulation, formulation design, process optimization, scale-up, technology transfer and stability — and to be the F&D lead during regulatory submissions.
Key Responsibilities
1. Section Leadership
- Lead the formulation team (Senior Executives, Executives, Junior Executives, Trainees) across pre-formulation, formulation design, process optimization, lab-scale and pilot-scale trials.
- Plan F&D portfolio — prioritize new products, ANDA / DMF deficiencies, and post-approval improvements.
- Mentor and develop second-line leadership; manage manpower planning and engagement.
2. Formulation Strategy & Pre-Formulation
- Approve literature reviews, reference product evaluation, patent landscape, regulatory status, and formulation strategy for new products.
- Approve pre-formulation study reports — physicochemical characterization of API and excipients, compatibility studies, solubility, stability.
- Approve formulation development strategy for tablets and pellets — wet granulation, dry granulation, direct compression, extrusion-spheronization, layering, and coating (aqueous and non-aqueous).
3. Tech Transfer & Compliance
- Approve technology transfer documents — TTD, FDR, MFR, FPS, PDF.
- Approve Product Development Report (PDR) for new and existing OSD products before submission and audit.
- Be the audit-facing person for F&D during regulatory and customer audits.
- Approve stability protocols and reports per ICH Q1A(R2), Q1B, Q1E.
- Drive ALCOA+ and data integrity compliance across F&D.
4. Cross-Functional Coordination
- Coordinate with ADL on analytical method development, validation, and stability analysis.
- Coordinate with Production for scale-up, process validation, and routine commercial troubleshooting.
- Coordinate with QA, RA on submission timelines, deficiency response, and post-approval changes.
5. Equipment Overseen
- Lab-scale and pilot-scale: Extruder, Spheronizer, Fluid Bed Dryer (FBD), Wurster Coater
- Rapid Mixer Granulator (RMG), Octagonal Blender
- Tablet Compression Machine, Tablet Coater
- Capsule Filling Machine, Tray Dryer
- Sieve shaker, Mill (Comil / Multimill)
Documentation & Compliance
- Follow ALCOA+ principles for data integrity.
- Adhere to cGMP, ICH Q8 / Q9 / Q10, and Schedule M norms.
- Approve and maintain TTD, FDR, MFR, FPS, PDF, Product Logbooks and Instrument Logbooks.
- Participate in internal audits, regulatory inspections, and CAPA closure.
- Ensure calibration and preventive maintenance of all F&D equipment is up to date.
Qualification
M.Pharm (Pharmaceutics)
Experience
8 – 12 years; multi-section / department-coordination level (OSD experience preferred).
Skills & Competencies
- Proven F&D leadership in regulated OSD pharma (tablets and pellets).
- Deep formulation expertise — wet / dry granulation, extrusion-spheronization, layering, coating.
- ICH Q8 / Q9 / Q10 (QbD) and DoE-based formulation experience.
- Strong technology-transfer and scale-up exposure.
- Excellent regulatory and customer audit-handling track record.
- ALCOA+ and data integrity rigour.
- Strategic, financial, and people leadership skills.
Frequently Asked Questions
Is the salary disclosed for the Assistant Manager- R&D Formulations & Development position at pell?
The salary for this Assistant Manager- R&D Formulations & 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 Assistant Manager- R&D Formulations & Development position at pell located?
This Assistant Manager- R&D Formulations & 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 Assistant Manager- R&D Formulations & Development role at pell full-time or part-time?
This is listed as a FULL TIME position. It is posted as a Assistant Manager- R&D Formulations & Development role in the R&D-Formulation & Development department at pell.
Which team or department does the Assistant Manager- R&D Formulations & Development at pell belong to?
This Assistant Manager- R&D Formulations & 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 Assistant Manager- R&D Formulations & 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 Assistant Manager- R&D Formulations & Development job at pell posted?
This Assistant Manager- R&D Formulations & Development position at pell was posted on Jul 28, 2026. Apply as soon as possible — early applications are often reviewed first.
Assistant Manager- R&D Formulations & Development
pell
You'll be redirected to pell's official application page on keka.