Senior Formulation & Development (F&D) Chemist

We Are Hiring

Education: M.Pharma / B.Pharma
Experience: 5–8 years in F&D, specifically in tablets & pellets formulation
Location: Wada

Job Summary

We are seeking a highly skilled and experienced Senior Formulation & Development (F&D) Chemist with strong expertise in solid oral dosage forms (tablets & pellets). The ideal candidate will have extensive hands-on experience in formulation development, process optimization, and regulatory documentation, particularly in preparing Product Development Reports (PDRs) in compliance with global regulatory standards.

Key Responsibilities

Formulation Development (Tablets & Pellets):

• Develop robust formulations for IR, MR, DR tablets & pellet dosage forms.
• Conduct pre-formulation studies, API characterization & excipient compatibility.
• Design and execute lab-scale, exhibit, and validation batches using QbD principles.
• Optimize formulation and process parameters for granulation, compression, coating, extrusion–spheronization, and pelletization.
• Support scale-up and technology transfer activities with pilot and manufacturing teams.

Documentation & PDR Preparation:

• Independently prepare Product Development Reports (PDRs) with justification for formulation strategy, process design, and scalability.
• Perform risk assessment (FMEA), stability analysis & troubleshooting.
• Prepare supporting documents such as MFR, FPSs in compliance with ICH, USFDA, EU, and other guidelines.

Regulatory & Quality Compliance:

• Ensure all development activities comply with cGMP, GLP, and regulatory standards.
• Support audits, dossier preparation, and regulatory submissions.

Collaboration & Leadership:

• Work closely with cross-functional teams – AR&D, QA, Packaging, Regulatory, and Manufacturing.
• Mentor and guide junior scientists in formulation trials, data interpretation, and documentation practices.
• Essential Skills:
• Strong knowledge of granulation, compression, coating, pelletization
• Expertise in PDR preparation and scientific documentation
• Experience in regulated markets (EU, Russia, Chile, ROW, etc.)
• Preferred: QbD exposure and regulatory filing experience

Key Competencies

• Technical expertise in solid oral dosage formulation & process development
• Strong problem-solving & analytical skills
• Proficiency in regulatory guidelines & documentation
• Excellent communication, leadership & mentoring skills

How to Apply:
Interested candidates can share their CV at
Glocalrise.komal@gmail.com
Contact: 9106329670

Job Types: Full-time, Permanent

Pay: ₹45,000.00 - ₹58,000.00 per month