Senior Formulation

1 week ago

Wada Thane Maharashtra, India GlocalRise HR Pvt Ltd Full time ₹ 45,000 - ₹ 58,000 per year

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

Contact:

Job Types: Full-time, Permanent

Pay: ₹45, ₹58,000.00 per month

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