f&d_ind_ra

4 days ago

Navi Mumbai, Maharashtra, India Alkem Laboratories Ltd. Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Job Purpose
To lead and support formulation development activities for solid and liquid dosage forms, including nutraceuticals, ensuring regulatory compliance and robust documentation for domestic submissions.

Key Responsibilities

  • Design and develop solid (tablets, capsules) and liquid (syrups, suspensions) dosage forms.
  • Conduct pre-formulation studies, prototype development, and scale-up trials.
  • Optimize formulations for stability, bioavailability, and manufacturability.
  • Develop innovative nutraceutical formulations aligned with market trends and therapeutic needs.
  • Evaluate functional ingredients, excipients, and delivery systems for efficacy and safety.
  • Prepare and review technical documentation for domestic regulatory submissions (FSSAI, CDSCO, etc.).
  • Ensure adherence to regulatory guidelines and pharmacopeial standards.
  • Design and execute stability protocols as per ICH guidelines.
  • Analyze stability data and prepare reports for product registration and shelf-life determination.
  • Support scale-up and technology transfer to manufacturing units.
  • Collaborate with cross-functional teams including QA, QC, RA, and Production.
  • Maintain comprehensive records of formulation trials, batch manufacturing records, and development reports.
  • Prepare product development reports and dossiers for internal and external audits.

Desired Candidate Profile

  • Education: M.Pharm / M.Sc. in Pharmaceutics or related field
  • Experience: 3–6 years in formulation development for domestic market
  • Hands-on experience in solid and liquid dosage forms
  • Knowledge of nutraceuticals and functional ingredients
  • Familiarity with domestic regulatory frameworks
  • Proficiency in stability study design and documentation
  • Strong analytical and problem-solving skills

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