Assistant Manager - Formulation & Development

Orchid Pharma; Kotputli; On-site; INR 600,000 - 900,000; Full time

Job summary

Orchid Pharma in India seeks a senior professional to lead formulation development for semisolid dosage forms including ointments, creams, and gels, ensuring quality, stability, efficacy, and regulatory compliance. The role includes CTD documentation and coordination of tech transfer to ensure regulatory market readiness.

You will plan and execute development targets, arrange required materials, and mentor department personnel, while conducting excipient compatibility and stability studies per

Responsibilities

• Strong expertise in formulation development and optimization of semisolid dosage forms, including ointments, creams, and gels, with proven experience in designing robust formulations to achieve desired quality, stability, efficacy, and regulatory compliance.
• Overall responsible for F&D related Execution and Planning.
• To ensure that develop products Ointment/ cream/gel as per EU Regulatory Market, Semi regulatory and ROW market.
• To ensure that the prepared CTD / Qbd Documentation.
• To meet development targets of formulation within the established standards with respect to material consumption and quality.
• To ensure to arrange all required materials (Raw Material & Miscellaneous) as per requirement.
• To plan for technical / behavioral, training and development of the department personnel.
• To ensure Responsible for Conducting Drug Excipient compatibility studies and Performing stability studies as per ICH.
• Responsible for Technology Transfer execution and coordination with all concern departments with all required documents, protocols and reports
• Followed the Guidelines as per Regulatory requirements.
• Responsible for Preparation and executing Master formula card and Product development report in CTD.
• Coordination with QA/QC, Production and Regulatory Teams for Product delivery within the time limit.

Job description

Role & responsibilities

• Strong expertise in formulation development and optimization of semisolid dosage forms, including ointments, creams, and gels, with proven experience in designing robust formulations to achieve desired quality, stability, efficacy, and regulatory compliance.
• Overall responsible for F&D related Execution and Planning.
• To ensure that develop products Ointment/ cream/gel as per EU Regulatory Market, Semi regulatory and ROW market.
• To ensure that the prepared CTD / Qbd Documentation.
• To meet development targets of formulation within the established standards with respect to material consumption and quality.
• To ensure to arrange all required materials (Raw Material & Miscellaneous) as per requirement.
• To plan for technical / behavioral, training and development of the department personnel.
• To ensure Responsible for Conducting Drug Excipient compatibility studies and Performing stability studies as per ICH.
• Responsible for Technology Transfer execution and coordination with all concern departments with all required documents, protocols and reports
• Followed the Guidelines as per Regulatory requirements.
• Responsible for Preparation and executing Master formula card and Product development report in CTD.
• Coordination with QA/QC, Production and Regulatory Teams for Product delivery within the time limit.